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BACKGROUND: We determined the impact of an increased two-stool faecal immunochemical test (FIT) cut-off on colonoscopy positivity and relative sensitivity and specificity in the randomized controlled screening trial screening of Swedish colons conducted in Sweden. METHODS: We performed a cross-sectional analysis of participants in the FIT arm that performed FIT between March 2014 and 2020 within the study registered with ClinicalTrials.gov, NCT02078804, who had a faecal haemoglobin concentration of at least 10 µg/g in at least one of two stool samples and who underwent a colonoscopy (n = 3841). For each increase in cut-off, we computed the positive predictive value (PPV), numbers needed to scope (NNS), sensitivity and specificity for finding colorectal cancer (CRC) and advanced neoplasia (AN; advanced adenoma or CRC) relative to cut-off 10 µg/g. RESULTS: The PPV for AN increased from 23.0% (95% confidence intervals [CI]: 22.3%-23.6%) at cut-off 10 µg/g to 28.8% (95% CI: 27.8%-29.7%) and 33.1% (95% CI: 31.9%-34.4%) at cut-offs 20 and 40 µg/g, respectively, whereas the NNS to find a CRC correspondingly decreased from 41 to 27 and 19. The PPV for AN was higher in men than women at each cut-off, for example 31.5% (95% CI: 30.1%-32.8%) in men and 25.6% (95% CI: 24.3%-27.0%) in women at 20 µg/g. The relative sensitivity and relative specificity were similar in men and women at each cut-off. CONCLUSION: A low cut-off of around 20-40 µg/g allows detection and removal of many AN compared to 10 µg/g while reducing the number of colonoscopies in both men and women.
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Colonoscopia , Neoplasias Colorretais , Detecção Precoce de Câncer , Sangue Oculto , Sensibilidade e Especificidade , Humanos , Estudos Transversais , Feminino , Masculino , Neoplasias Colorretais/diagnóstico , Pessoa de Meia-Idade , Detecção Precoce de Câncer/métodos , Idoso , Suécia , Fezes/química , Hemoglobinas/análise , Valor Preditivo dos Testes , Adenoma/diagnóstico , ImunoquímicaRESUMO
AIM: Since December 2015, a faecal immunochemical test (FIT) has been provided to primary care in NHS Tayside as an adjunct to clinical acumen in the assessment of new-onset bowel symptoms. The aim of this work was to assess the impact of this approach on time to diagnosis of colorectal cancer (CRC). METHOD: NHS Tayside Cancer audit data from January 2013 to December 2019 were reviewed to identify all CRC patients diagnosed via the primary-care referral pathway for a period before and after the introduction of FIT. Their electronic patient records were accessed and date of referral and any contemporaneous FIT and full blood count (FBC) result were recorded. Time from referral to diagnosis of CRC was calculated for each patient and compared between subgroups. RESULTS: The study cohort consisted of 959 patients: 378 and 581 from the time periods before and after the introduction of FIT, respectively. The median time to diagnosis before FIT was 30 days [interquartile range (IQR) 16-57 days] versus 25 days (IQR 14-47 days) following the introduction of FIT (p = 0.006). Following the introduction of FIT, patients who completed a FIT had a median of time to diagnosis of 23 days (IQR 14-43 days) compared with 30 days (IQR 16-62 days) for patients not completing a FIT (p = 0.019). FBC results were available for 97.5% of FIT patients to aid safety-netting of patients with a low or undetectable faecal haemoglobin concentration. CONCLUSION: The introduction of FIT-based triage of new bowel symptoms in primary care as an adjunct to clinical acumen is associated with a reduced time to CRC diagnosis.
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Neoplasias Colorretais , Detecção Precoce de Câncer , Sangue Oculto , Atenção Primária à Saúde , Triagem , Humanos , Neoplasias Colorretais/diagnóstico , Feminino , Masculino , Pessoa de Meia-Idade , Idoso , Triagem/métodos , Detecção Precoce de Câncer/métodos , Fatores de Tempo , Encaminhamento e Consulta/estatística & dados numéricos , Fezes/química , Estudos Retrospectivos , Imunoquímica/métodosRESUMO
AIM: Faecal immunochemical tests (FIT) are highly sensitive for colorectal cancer (CRC) detection. Little evidence exists regarding repeat FIT. The repeat FIT (RFIT) study aimed to determine whether second and third FIT provide reassurance and improve CRC or significant bowel disease (SBD) identification. METHODS: This was a prospective observational study. Patients recruited from urgent referrals returned three FIT and underwent colonoscopy. Chi-square tests compared categorical data. Diagnostic accuracy variables (sensitivity/specificity/positive predictive value [PPV]/negative predictive value [NPV]) were calculated for one, two and three FIT (95% CI). Three negative FIT (<10 µg Hb/g of faeces [µg/g]) groups (one, two, three) were compared with positive groups (one or more FIT ≥10 µg/g). CRC and SBD detection rates were compared by strategy. RESULTS: A total of 460 patients (mean age: 66.8 years, 233 males and 227 females, 23 CRC, 80 SBD) were included in the study. For one, two and three negative FIT, CRC sensitivity remained static (95.7%); specificity (44.6%, 40.7% and 38.4%) and NPV decreased (99.5%, 99.4% and 99.4%). For SBD, sensitivity increased (78.8%, 83.8% and 86.3%), specificity decreased (47.4%, 43.7% and 41.6%) and NPV increased (91.4%, 92.7% and 93.5%). In one, two and three positive FIT groups, CRC detection was 8.3%,16.1% and 20.9%. CRC mean FIT was 150 µg/g, <6 µg/g for benign pathology. CONCLUSIONS: One or more negative FIT increases the sensitivity for CRC/SBD. Repeating FIT provides greater differentiation of patients with and without CRC/SBD compared to single FIT but is associated with decreased specificity and PPV. Multiple negative FIT may offer reassurance; however, application of repeating FIT may be restricted given the associated increase in investigations S1.
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AIM: Faecal immunochemical testing (FIT) is used in the detection of colorectal cancer (CRC). FIT is invariably used at a single faecal haemoglobin (f-Hb) concentration threshold. The aim of this observational study was to explore risk scoring models (RSMs) with f-Hb and other risk factors for CRC in symptomatic patients attending primary care, potentially speeding diagnosis and saving endoscopy resources. METHOD: Records of patients completing FIT were linked with The Scottish Cancer Registry and with other databases with symptoms, full blood count and demographic variables, and randomized into derivation and validation cohorts. Stepwise multivariable logistic regression created RSMs assessed in the validation cohort. RESULTS: Of 18 805 unique patients, 9374 and 9431 were in the derivation and validation cohorts, respectively: f-Hb, male sex, increasing age, iron deficiency anaemia and raised systemic immune inflammation index created the final RSM. A risk score threshold of ≥2.363, generating the same number of colonoscopies as a f-Hb threshold of ≥10 µg Hb/g gave improved sensitivity for CRC in both cohorts. A RSM which excluded f-Hb was used to investigate the effect of raising the f-Hb threshold from ≥10 to ≥20 µg Hb/g in those with a low risk score. This approach would have generated 234 fewer colonoscopies but missed four CRCs. CONCLUSION: The RSM conferred no significant benefit to patients with very low f-Hb and CRC. Alternative strategies combining FIT with other variables may be more appropriate for safety-netting of symptomatic patients. Further work to develop and investigate the value of RSM for significant bowel disease other than CRC may also be beneficial.
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Neoplasias Colorretais , Detecção Precoce de Câncer , Hemoglobinas , Sangue Oculto , Atenção Primária à Saúde , Humanos , Masculino , Hemoglobinas/análise , Feminino , Pessoa de Meia-Idade , Neoplasias Colorretais/diagnóstico , Idoso , Medição de Risco , Detecção Precoce de Câncer/métodos , Fatores de Risco , Colonoscopia/estatística & dados numéricos , Fezes/química , Modelos Logísticos , Escócia , Sensibilidade e Especificidade , Imunoquímica , Anemia Ferropriva/diagnósticoRESUMO
Repeated rounds of faecal immunochemical testing (FIT) for occult blood is a common method for screening for colorectal cancer (CRC). However, the time interval between FIT rounds is not thoroughly investigated. In a CRC screening trial in South-Eastern Norway, individuals were invited for biennial FIT between 2012 and 2019. The positivity threshold was >15 mcg haemoglobin/g faeces (mcg/g). Due to organizational challenges, the interval between screening rounds randomly varied between 1.5 and 3.5 years, forming a natural experiment. We investigated the detection rate of CRC and advanced neoplasia (AN: CRC or advanced adenoma) at the subsequent round (FIT2 ), according to the faecal haemoglobin concentration (f-Hb) at the initial screening round (FIT1 ), and time between the two screening rounds. 18 522 individuals with negative FIT1 who attended FIT2 were included in this study. 245 AN were detected at FIT2 , of which 34 were CRC. The CRC detection rate at FIT2 for participants with FIT1 = 0 mcg/g was 0.09% while it was 0.28% for participant with 0 > FIT1 ≤ 15 mcg/g; odds ratio (OR) 3.22, 95% CI 1.49-6.95. For each 3 months' increment between FITs, the OR for detecting CRC was 1.33 (95% CI 0.98-1.79), while the OR was 1.13 (1.02-1.26) for AN. Individuals with FIT1 -value of 0 mcg/g, had a lower AN detection rate compared with participants with 0 > FIT1 ≤ 15 mcg/g, irrespective of time between tests. Although CRC and AN detection rates increase with increasing time interval between FITs, individuals with undetectable f-Hb at first screen have substantially lower risk of CRC at the next screening round compared with individuals with detectable f-Hb.
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Neoplasias Colorretais , Sangue Oculto , Humanos , Detecção Precoce de Câncer/métodos , Hemoglobinas/análise , Razão de Chances , Neoplasias Colorretais/diagnóstico , Fezes/química , Programas de Rastreamento/métodos , ColonoscopiaRESUMO
BACKGROUND: Colorectal cancer (CRC) screening reduces all-cause and CRC-related mortality. New research demonstrates that the faecal haemoglobin concentration (f-Hb) may indicate the presence of other serious diseases not related to CRC. We investigated the association between f-Hb, measured by a faecal immunochemical test (FIT), and both all-cause mortality and cause of death in a population-wide cohort of screening participants. METHODS: Between 2014 and 2018, 1,262,165 participants submitted a FIT for the Danish CRC screening programme. We followed these participants, using the Danish CRC Screening Database and several other national registers on health and population, until December 31, 2018. We stratified participants by f-Hb and compared them using a Cox proportional hazards regression on all-cause mortality and cause of death reported as adjusted hazard ratios (aHRs). We adjusted for several covariates, including comorbidity, socioeconomic factors, demography and prescription medication. RESULTS: We observed 21,847 deaths in the study period. Our multivariate analyses indicated an association relationship between increasing f-Hb and the risk of dying in the study period. This risk increased steadily from aHR 1.38 (95% CI: 1.32, 1.44) in those with a f-Hb of 7.1-11.9 µg Hb/g faeces to 2.20 (95% CI: 2.10, 2.30) in those with a f-Hb ≥60.0 µg Hb/g faeces, when compared to those with a f-Hb ≤7.0 µg Hb/g faeces. The pattern remained when excluding CRC from the analysis. Similar patterns were observed between incrementally increasing f-Hb and the risk of dying from respiratory disease, cardiovascular disease and cancers other than CRC. Furthermore, we observed an increased risk of dying from CRC with increasing f-Hb. CONCLUSIONS: Our findings support the hypothesis that f-Hb may indicate an elevated risk of having chronic conditions if causes for the bleeding have not been identified. The mechanisms still need to be established, but f-Hb may be a potential biomarker for several non-CRC diseases.
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Neoplasias Colorretais , Detecção Precoce de Câncer , Humanos , Causas de Morte , Neoplasias Colorretais/diagnóstico , Fezes/química , Hemoglobinas/análise , Sangue Oculto , Colonoscopia , Programas de RastreamentoRESUMO
BACKGROUND: Colorectal cancer (CRC) is one of the most common cancers and is associated with high incidence and mortality rates worldwide. CRC has caused a tremendous loss of human health and wealth. The incidence and mortality of colorectal carcinoma are increasing in young adults. Early cancer detection and prevention are made possible through screening. At present, the faecal immunochemical test (FIT) is a noninvasive method that can be used for the large-scale clinical screening of CRC status. Therefore, this study, based on CRC screening results in Tianjin from 2012 to 2020, was conducted to analyse the major differences in diagnostic performance parameters according to sex and age. METHODS: This study was based on 39,991 colonoscopies performed for individuals in the Tianjin CRC screening program from 2012 to 2020. Of these individuals, they had complete FIT and colonoscopy results. The differences in FIT results were analysed by sex and age. RESULTS: According to this study, males were generally more likely to develop advanced neoplasms (ANs) than females, and the prevalence increased with age. Males with negative FIT results were more likely to have advanced neoplasms than females with positive results. The accuracy of the FIT in detecting ANs in each age group was 54.9%, 45.5%, 48.6% and 49.5% in the 40-49, 50-59, 60-69, and ≥ 70 age groups, respectively. CONCLUSIONS: The FIT detected ANs with highest accuracy in the 40-49 age group. Our research can provide guidance to formulate CRC screening strategies.
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Neoplasias Colorretais , Programas de Rastreamento , Masculino , Feminino , Humanos , Adolescente , Adulto , Pessoa de Meia-Idade , Programas de Rastreamento/métodos , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/epidemiologia , Sangue Oculto , Detecção Precoce de Câncer/métodos , Colonoscopia/métodos , FezesRESUMO
AIM: To establish patient factors associated with a successful colon capsule endoscopy (CCE) test. METHOD: This prospective cohort study used data collected from patients who underwent CCE as part of the ScotCap evaluation prior to April 2020. A CCE was defined as successful if the capsule visualized the whole colon and rectum (complete test) with sufficient bowel cleansing to permit assessment of the colonic mucosa (adequate bowel preparation). Factors from patients in symptomatic and surveillance groups were analysed for associations with a successful test, complete test, adequate bowel preparation and requirement for further procedure using univariate, multivariate logistic, least absolute shrinkage and selection operator regression. RESULTS: Data from 263 symptomatic and 137 surveillance patients were analysed. There was an association between a symptomatic patient's age and a successful test (OR = 0.97, 95% CI: 0.95-0.99), adequate bowel preparation (OR = 0.97, 95% CI: 0.94-1.00) and further procedure requirement (OR = 1.04, 95% CI: 1.02-1.06). An association was found, for symptomatic patients, between a faecal immunochemical test result in the range 10-399 µg/g and a further procedure (OR = 2.32, 95% CI: 1.23-4.48). In patients undergoing surveillance for previous colorectal cancer (OR = 0.42, 95% CI: 0.18-0.97), had previous bowel resection surgery (OR = 0.43, 95% CI: 0.19-0.98) or took a beta blocker medication (OR = 0.32, 95% CI: 0.11-0.88), an association was found with further procedure requirement. CONCLUSIONS: Among symptomatic patients, younger age was associated with obtaining a successful CCE test. Clinicians could consider patient selection based on these results to improve the rate of successful testing in clinical practice.
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Endoscopia por Cápsula , Neoplasias Colorretais , Humanos , Endoscopia por Cápsula/métodos , Estudos Prospectivos , Colonoscopia/métodosRESUMO
BACKGROUND: Accumulating evidence now indicates that the presence of faecal haemoglobin, in the absence of gastrointestinal bleeding, may be an indicator of systemic inflammation and is linked to the development of human diseases. We evaluated whether a positive faecal immunochemical test (FIT) is associated with the development of immune-mediated inflammatory diseases (IMIDs). METHODS: Data from the nationwide colorectal cancer screening programme from 2009 to 2013 were used. Participants (n=8,646,887) were divided into FIT (+) and FIT (-) groups by performing a 1:1 random sampling matched by age and sex. Participants with concurrent haemorrhoids, colorectal cancer (CRC), inflammatory bowel disease (IBD), and missed CRC and IBD were excluded using the colonoscopy results, ICD-10 codes, and the special exemption code (V code). Endpoints were the incidence of IMIDs (rheumatoid arthritis [RA], systemic lupus erythematosus [SLE], and psoriatic arthritis [PsA]) after FIT. RESULTS: Of the 1,044,955 eligible participants, 229,594 and 815,361 individuals were included in the FIT (+) and the FIT (-) groups, respectively. During the mean follow-up period of 7.59 years, a total of 7645 (incidence rate [IR] 9.56/10,000 person-years [PY]), 208 (IR 0.26/10,000 PY), and 101 (IR 0.13/10,000 PY) patients were diagnosed with RA, SLE, and PsA, respectively. An adjusted Cox analysis demonstrated that FIT positivity conferred a 1.16 (95% confidence interval [CI] 1.09-1.24, p<0.001) times greater risk of developing RA. Kaplan-Meier analysis in the 1:2 propensity-score matched population also confirmed these results (hazard ratio [HR] 1.18, 95% CI 1.10-1.27, p<0.001). CONCLUSIONS: Positive FIT is associated with increased risk of RA in the general population, corroborating that aberrancies of gut mucosa are associated with the development of IMIDs. Vigilant monitoring and early referral to a specialist upon medical suspicion is required in this population. TRIAL REGISTRATION: Retrospectively registered.
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Artrite Psoriásica , Artrite Reumatoide , Neoplasias Colorretais , Doenças Inflamatórias Intestinais , Lúpus Eritematoso Sistêmico , Artrite Psoriásica/diagnóstico , Artrite Psoriásica/epidemiologia , Artrite Reumatoide/diagnóstico , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/epidemiologia , Detecção Precoce de Câncer/métodos , Humanos , Incidência , Doenças Inflamatórias Intestinais/diagnóstico , Doenças Inflamatórias Intestinais/epidemiologiaRESUMO
OBJECTIVES: Faecal immunochemical tests for haemoglobin (FIT) are used in colorectal cancer (CRC) screening programmes and to triage patients presenting with symptoms suggestive of CRC for further bowel investigations. There are a number of quantitative FIT analytical systems available. Currently, there is no harmonisation or standardisation of FIT methods. The aim of the study was to assess the comparability of numerical faecal haemoglobin concentrations (f-Hb) obtained with four quantitative FIT systems and the diagnostic accuracy at different f-Hb thresholds. METHODS: A subgroup of the National Institute for Health and Care Excellence (NICE) FIT study, a multicentre, prospective diagnostic accuracy study were sent four FIT specimen collection devices from four different FIT systems or two FIT devices for one FIT system. Faecal samples were examined and analysis of results carried out to assess difference between methods at thresholds of limit of detection (LoD), 10 µg haemoglobin/g faeces (µg/g) and 100 µg/g. RESULTS: 233 patients returned specimen collection devices for examination on four different systems; 189 patients returned two FIT kits for one system. At a threshold of 100 µg/g the sensitivity is the same for all methods. At lower thresholds of LoD and 10 µg/g differences were observed between systems in terms of patients who would be referred and diagnostic accuracies. CONCLUSIONS: The lack of standardisation or harmonisation of FIT means that differences are observed in f-Hb generated on different systems. Further work is required to understand the clinical impact of these differences and to minimise them.
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Neoplasias Colorretais , Enteropatias , Colonoscopia , Neoplasias Colorretais/diagnóstico , Detecção Precoce de Câncer/métodos , Fezes/química , Hemoglobinas/análise , Humanos , Sangue Oculto , Estudos Prospectivos , Sensibilidade e EspecificidadeRESUMO
Currently, women are disadvantaged compared to men in colorectal cancer (CRC) screening, particularly in programmes that use faecal immunochemical tests for haemoglobin (FIT) followed by colonoscopy. Although there is no single cause for all the known disadvantages, many can be attributed to the ubiquitous finding that women have lower faecal haemoglobin concentrations (f-Hb) than men; there are many plausible reasons for this. Generally, a single f-Hb threshold is used in CRC screening programmes, leading to lower positivity for women than men, which causes poorer outcomes for women, including lower CRC detection rate, higher interval cancer (IC) proportion, and higher CRC mortality. Many of the now widely advocated risk scoring strategies do include factors taking account of sex, but these have not been extensively piloted or introduced. Using different f-Hb thresholds for the sexes seems advantageous, but there are difficulties, including deciding which characteristic should be selected to achieve equivalency, for example, positivity, IC proportions, or specificity. Moreover, additional colonoscopy resources, often constrained, would be required. Governments and their agencies should be encouraged to prioritise the allocation of resources to put simple strategies into practice, such as different f-Hb thresholds to create equal positivity in both sexes.
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Neoplasias Colorretais , Detecção Precoce de Câncer , Colonoscopia , Fezes , Feminino , Hemoglobinas , Humanos , Masculino , Programas de Rastreamento , Sangue OcultoRESUMO
BACKGROUND AND AIM: Surveillance colonoscopies may be delayed because of pressure on resources, such as the COVID-19 pandemic. This study aimed to determine whether delayed surveillance colonoscopy increases the risk for advanced neoplasia and whether interval screening with faecal immunochemical tests (FITs) and other known risk factors can mitigate this risk. METHODS: A retrospective cohort study of individuals undergoing surveillance colonoscopy for personal or family history of colorectal neoplasia was being provided with FIT between colonoscopies. Colonoscopy ≥ 6 months after the guideline-recommended interval was considered "delayed." Individuals were stratified based on prime colonoscopy findings to nonneoplastic findings, non-advanced adenoma, and advanced adenoma. The relative risk (RR) for developing advanced neoplasia was determined using a robust multivariable modified Poisson regression. RESULTS: Of 2548 surveillance colonoscopies, 1457 (57.18%) were delayed. Prior advanced adenoma, older age (> 60 years) and nonparticipation in interval FIT were associated with increased risk for advanced neoplasia (P < 0.05). There was a trend to increased risk in those with prior advanced adenoma with an increasing colonoscopy delay (P trend = 0.01). In participants who did not complete interval FIT and having advanced adenoma in the prime colonoscopy, risk of advanced neoplasia was 2.48 times higher (RR = 2.48, 95% confidence interval: 1.20-5.13) in participants who had beyond 2 years of delayed colonoscopy compared with those with on-time colonoscopy. Colonoscopy delay did not increase the risk of advanced neoplasia in participants with negative interval FIT results. CONCLUSION: Surveillance colonoscopy can be safely extended beyond 6 months in elevated colorectal cancer risk patients who do not have prior advanced adenoma diagnosis, particularly if interval FIT is negative.
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Adenoma , COVID-19 , Neoplasias Colorretais , Adenoma/diagnóstico , Adenoma/epidemiologia , Adenoma/prevenção & controle , Colonoscopia/métodos , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/epidemiologia , Neoplasias Colorretais/prevenção & controle , Detecção Precoce de Câncer/métodos , Humanos , Sangue Oculto , Pandemias , Estudos Retrospectivos , Fatores de RiscoRESUMO
AIM: To determine the efficacy of a new 2-week wait pathway that uses the faecal immunochemical test (FIT) in primary care to triage patients with high and low risk symptoms suspicious of colorectal cancer (CRC). This service improvement pilot follows 2017 National Institute for Health and Care Excellence guidance, that recommended using FIT to guide referral of patients with low risk, but not high risk symptoms, which continue to be referrred on the 2-week pathway. METHOD: Patients with high- and low-risk CRC symptoms were tested with FIT and those with faecal haemoglobin (f-Hb) ≥9.5 µg haemoglobin/g faeces (hereafter µg/g) were referred to secondary care. Results were tracked and primary care prompted to refer if timely referral was not made. RESULTS: Between December 2019 and October 2020, 5672 patients presented to primary care with high and/or low risk symptoms warranting investigations. Of these, 622 (11%) patients were referred without a FIT, of whom 36 (5.8%) had CRC. The remaining 5050 patients had a FIT, of which 4187 (83%) were processed to produce a quantitative result. Of these, 1085 patients (25.9%) had an f-Hb ≥9.5 µg/g and of those, 982 patients (90.5%) were referred and 56 (5.7%) had CRC. A total of 3102 patients (74.1%) had an f-Hb <9.5 µg/g, of which 456 (14.7%) were referred and three (0.7%) had CRC. A total of 97 cancers were diagnosed with a cancer prevalence of 1.7%. CONCLUSION: A 2-week wait pathway incorporating FIT as a triage tool can be implemented successfully in primary care to identify symptomatic patients at highest risk of CRC.
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Neoplasias Colorretais , Humanos , Neoplasias Colorretais/diagnóstico , Sensibilidade e Especificidade , Hemoglobinas/análise , Fezes/química , Colonoscopia , Sangue Oculto , Detecção Precoce de Câncer/métodos , Atenção Primária à SaúdeRESUMO
AIM: The COLO-COHORT study aims to produce a multi-factorial risk prediction model for colorectal neoplasia that can be used to target colonoscopy to those at greatest risk of colorectal neoplasia, ensuring that people are not investigated unnecessarily and maximizing the use of limited endoscopy resources. The study will also explore the link between neoplasia and the human gut microbiome. Additionally, the study aims to generate a cohort of colonoscopy patients who are 'research ready' through the development of a consent-for-contact (C4C) platform, to facilitate a range of colorectal cancer prevention studies to be conducted at scale and speed. METHODS AND ANALYSIS: This is a multi-centre observational study involving sites across the UK. Recruitment is over a 6-year period (2019-2025). Patients recruited to the study are those attending for colonoscopy. Patients are recruited into two groups, namely observational group A (10 000 patients) and C4C group B (10 000 patients), known as COLO-SPEED (Colorectal Cancer Screening Prevention Endoscopy and Early Diagnosis; https://colospeed.uk). Patients complete a health questionnaire, provide anthropometric measurements and submit biosamples (blood and stool-depending on the part of the study they are recruited into). Patients' colonoscopy and histology findings are also recorded. Models of factors associated with the presence of neoplasia at colonoscopy will be developed using logistic or multinomial regression. For internal validation, model discrimination and calibration will be assessed and bootstrapping and cross-validation approaches used. To enable long-term follow-up for outcomes related to colorectal cancer and polyps, patients are asked to consent to follow-up through data linkage with national databases. DISSEMINATION: In keeping with good research practice, following analysis by the study team the study investigators will make the anonymized dataset available to other researchers. The C4C platform will also be accessible to other researchers. The study findings will be submitted for publication in peer-reviewed journals and lay summaries will be disseminated to participants and the wider public.
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Colonoscopia , Neoplasias Colorretais , Humanos , Estudos de Coortes , Detecção Precoce de Câncer/métodos , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/etiologia , Neoplasias Colorretais/patologia , Consentimento Livre e Esclarecido , Sangue Oculto , Estudos Observacionais como Assunto , Estudos Multicêntricos como AssuntoRESUMO
AIMS: The faecal immunochemical test (FIT) is used every 2 years to screen average-risk British Columbians aged 50-74 years, with follow-up colonoscopy for positive results. Non-screen-detected colorectal adenocarcinomas are defined as those detected within 25 months following a negative FIT. We aimed to more clearly characterise these malignancies. METHODS AND RESULTS: A medical chart and focused pathology review of colorectal malignancies from 926 individuals who completed FIT in the British Columbia Colon Screening Program in 2014, and whose pathology reports were available for review, was conducted. This cohort was divided into two groups: individuals with colorectal adenocarcinomas diagnosed following a positive FIT (screen-detected) and individuals with colorectal adenocarcinoma diagnosed within 25 months of a negative FIT (FIT-interval cancers). Rates of clinically relevant pathological parameters, as outlined in the American Joint Committee on Cancer (AJCC), 8th edition, were compared between the screen-detected and FIT-interval cancer groups. A total of 876 screen-detected and 50 FIT-interval cancers were identified. FIT-interval cancers exhibited higher rates of high-grade differentiation (including poorly differentiated and undifferentiated cases; P < 0.01) and aggressive histotype (signet ring cell and mucinous carcinomas; P < 0.01) than did screen-detected cancers after Bonferroni correction. Colorectal adenocarcinoma diagnosed after a negative FIT may therefore be associated with worse prognostic determinants than screen-detected cancers. CONCLUSION: FIT-interval cancers are associated with high-risk pathological features; the possibility that more aggressive, fast-growing lesions which arise in the interval after truly negative FITs cannot be ruled out. Further study of a larger cohort of FIT-interval cancers controlling for interaction among the different pathologic parameters will be undertaken.
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Adenocarcinoma , Neoplasias Colorretais , Detecção Precoce de Câncer/métodos , Adenocarcinoma/diagnóstico , Adenocarcinoma/patologia , Idoso , Estudos de Coortes , Colo/patologia , Colonoscopia , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/patologia , Feminino , Humanos , Masculino , Programas de Rastreamento/métodos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , PrognósticoRESUMO
OBJECTIVES: Currently, NICE recommends the use of faecal immunochemical test (FIT) at faecal haemoglobin concentrations (f-Hb) of 10 µg Hb/g faeces to stratify for colorectal cancer (CRC) risk in symptomatic populations. This f-Hb cut-off is advised across all analysers, despite the fact that a direct comparison of analyser performance, in a clinical setting, has not been performed. METHODS: Two specimen collection devices (OC-Sensor, OC-S; HM-JACKarc, HM-J) were sent to 914 consecutive individuals referred for follow up due to their increased risk of CRC. Agreement of f-Hb around cut-offs of 4, 10 and 150 µg Hb/g faeces and CRC detection rates were assessed. Two OC-S devices were sent to a further 114 individuals, for within test comparisons. RESULTS: A total of 732 (80.1%) individuals correctly completed and returned two different FIT devices, with 38 (5.2%) CRCs detected. Median f-Hb for individuals diagnosed with and without CRC were 258.5 and 1.8 µg Hb/g faeces for OC-S and 318.1 and 1.0 µg Hb/g faeces for HM-J respectively. Correlation of f-Hb results between OC-S/HM-J over the full range was rho=0.74, p<0.001. Using a f-Hb of 4 µg Hb/g faeces for both tests found an agreement of 88.1%, at 10 µg Hb/g faeces 91.7% and at 150 µg Hb/g faeces 96.3%. A total of 114 individuals completed and returned two OC-S devices; correlation across the full range was rho=0.98, p<0.001. CONCLUSIONS: We found large variations in f-Hb when different FIT devices were used, but a smaller variation when the same FIT device was used. Our data suggest that analyser-specific f-Hb cut-offs are applied with regard to clinical decision making, especially at lower f-Hb.
Assuntos
Neoplasias Colorretais , Imunoensaio/métodos , Colonoscopia , Neoplasias Colorretais/diagnóstico , Detecção Precoce de Câncer , Fezes/química , Hemoglobinas/análise , Humanos , Sangue Oculto , Encaminhamento e ConsultaRESUMO
PURPOSE: Colorectal cancer (CRC) screening has been shown to improve patient outcomes. A widely utilised preliminary screening tool is the faecal immunochemical test (FIT). However, follow-up rates after a positive FIT result remain suboptimal. METHODS: In order to improve FIT-positive individuals' compliance to follow-up consultation and to elucidate barriers to action, a simple 5- to 10-min telephone intervention with a structured script based on the protection motivation theory (PMT) was conducted. RESULTS: Ninety-two FIT-positive individuals who had previously rejected follow-up consultation in the National University Hospital, Singapore, were interviewed by the study team. Individuals reported barriers to action such as the denial of a positive FIT result (41.8%) and a lack of knowledge (34.5%). More than 20% of the participants who had yet to schedule follow-up consultation changed their minds after the intervention. CONCLUSION: The results suggest that a simple, structured telephone call can potentially encourage more FIT-positive individuals to pursue follow-up investigation.
Assuntos
Neoplasias Colorretais , Sangue Oculto , Neoplasias Colorretais/diagnóstico , Detecção Precoce de Câncer , Humanos , Programas de Rastreamento , SingapuraRESUMO
AIM: The faecal immunochemical test (FIT) is currently utilized in both symptomatic and screening populations, but little is known about factors that affect its performance. For example, proton pump inhibitor (PPI) therapy has been purported to increase false negative rates. This has significant implications given the extent of PPI prescriptions. The aim of this work was to evaluate the performance of the FIT for the detection of colorectal neoplasms and the impact of PPI therapy on its diagnostic accuracy. METHOD: Symptomatic patients referred on the suspected cancer pathway and those on polyp surveillance between 2015 and 2019 were approached to participate. Estimates of the accuracy of FIT at different cut-off levels in diagnosing colorectal neoplasms were made. Logistic regression was used to assess the effect of PPIs on the FIT results. RESULTS: A total of 667 participants were eligible for the final analysis. At a cut-off of 10 µg/g faeces, the overall sensitivity and specificity of FIT for the detection of colorectal cancer (CRC) was 0.85 (95% CI 0.71-0.94) and 0.81 (95% CI 0.78-0.84), respectively. For the detection of advanced neoplasia, the sensitivity was 0.70 (95% CI 0.58-0.79) and the specificity was 0.83 (95% CI 0.80-0.86). At higher thresholds, the sensitivity steadily declined whilst specificity increased. PPI therapy did not have a significant effect on performance of the FIT. CONCLUSION: FIT is a good rule-out test for the detection of CRC and advanced neoplasia at lower thresholds. PPI therapy does not appear to have an effect on its diagnostic performance.
Assuntos
Neoplasias Colorretais , Inibidores da Bomba de Prótons , Colonoscopia , Neoplasias Colorretais/diagnóstico , Detecção Precoce de Câncer , Fezes/química , Hemoglobinas/análise , Humanos , Programas de Rastreamento , Sangue Oculto , Inibidores da Bomba de Prótons/uso terapêutico , Sensibilidade e EspecificidadeRESUMO
AIM: The aim of this work was to investigate whether the faecal immunochemical test (FIT) could safely rule out colorectal cancer (CRC) in patients with rectal bleeding (RB). METHOD: This was a multicentre, double-blinded diagnostic accuracy study in 50 National Health Service hospitals. Patients referred from primary care with suspected CRC on an urgent 2-week-wait pathway were asked to perform a FIT prior to colonoscopy. The primary outcome measure was the sensitivity of the FIT for CRC in patients with RB versus nonrectal bleeding symptoms (NRB). The secondary outcome measures included the diagnostic accuracy of the FIT for CRC and other serious bowel disease. RESULTS: Of 9822 patients included in the study, 3143 (32.0%) were referred with RB. CRC was present in 4.7% of patients with RB versus 2.7% of patients with NRB (p < 0.05). Faecal haemoglobin (f-Hb) was detectable (>2 µg/g) in 44.1% of patients with RB and 33.9% with NRB (p < 0.05). In RB patients, CRC was present in 10.4% when f-Hb was >2 µg/g compared with 0.1% when f-Hb was not detected. Flexible sigmoidoscopy in this group would further reduce the risk of CRC to 0.03%. The sensitivity of the FIT for CRC in RB versus NRB groups was 98.6% (95% CI 95.2%-99.8%) vs 95.6% (91.5%-98.1%) for f-Hb >2 µg/g and 96.6% (92.2%-98.9%) vs 86.3 (80.4%-90.9%) for f-Hb >10 µg/g. CONCLUSION: Faecal haemoglobin is not always detectable in patients with RB; 56% of patients had undetectable f-Hb (<2 µg/g) and CRC was present in 0.1%. The high sensitivity of the FIT can be used to rule out CRC in patients with RB and triage them more appropriately for investigation.
Assuntos
Neoplasias Colorretais , Medicina Estatal , Colonoscopia , Neoplasias Colorretais/complicações , Neoplasias Colorretais/diagnóstico , Método Duplo-Cego , Detecção Precoce de Câncer , Fezes/química , Hemoglobinas/análise , Humanos , Sangue Oculto , Sensibilidade e EspecificidadeRESUMO
AIM: Detection of early onset colorectal cancer is challenging, and remains a rare diagnosis amongst younger people with gastrointestinal symptoms. We investigated whether faecal immunochemical testing (FIT) could identify younger patients at higher risk of colorectal cancer or serious bowel disease including colorectal cancer, inflammatory bowel disease or advanced adenomas. METHODS: A subgroup analysis was performed of symptomatic patients under 50 years of age (<50) from the NICE FIT study, a multicentre, prospective diagnostic accuracy study of FIT conducted between October 2017 and December 2019. The diagnostic accuracy of FIT for colorectal cancer and serious bowel disease was investigated in younger patients at different faecal haemoglobin (f-Hb) cut-offs of 2, 10 and 150 µg blood/g faeces (µg/g). RESULTS: Early onset colorectal cancer was diagnosed in 1.5% (16/1103) of younger symptomatic patients. The sensitivity of FIT for younger patients aged <50 was 87.5% (95% CI 61.7%-98.4%), 81.3% (54.4%-96.0%) and 68.8% (41.3%-89.0%) at f-Hb cut-offs of 2, 10 and 150 µg/g, respectively. The positive predictive value for colorectal cancer increased from 4.2% (2.3%-6.9%) to 11.5% (5.9%-19.6%) at cut-offs of 2 and 150 µg/g, while the positive predictive value for serious bowel disease increased from 31.3% (26.3%-36.5%) to 65.6% (55.2%-75.0%) at the same cut-offs. The negative predictive value of FIT for colorectal cancer remained above 99.5% at all cut-offs. CONCLUSION: Detectable f-Hb on FIT in symptomatic younger patients may indicate referral for investigation of colorectal cancer and serious bowel disease.