The Usefulness of an Online Simplified Screening Questionnaire (SSQ) in Identifying Work-Related Cancers.

To obtain a history of occupational exposure in the workplace, the questionnaire is one of the main sources of information. The aim of this study was to develop an online questionnaire using the REDCap data management platform based on the Work-Related Cancer Surveillance Guidelines, reported by the Brazilian National Cancer Institute. Several issues were taken into consideration for its routine application. It should be simple, easy, capable of being applied in a short time and used in the clinical setting of collecting information on the occupational history of the cancer patient. Consequently, this could enable the compulsory notification of work-related cancer. The questionnaire was developed based on questions about the use of and exposure to carcinogenic factors at work and due to smoking. An entirely electronic version of the cancer patient interview was performed using tablets. The online questionnaire was applied at the Barretos Cancer Hospital, Barretos, to newly diagnosed patients from July 2016 to 2018. A total of 1063 patients were included, and 550 indicated positively when asked "Do you work, or have you worked with this substance and/or in this function?/job?" Of these potentially notified patients, 38 subsequently had compulsorily reported work-related cancer. Another important result of this study was the creation and development of a website. In conclusion, we developed an online tool that could facilitate hospital routines, contributing to generating data for the compulsory notification of work-related cancer and triggering investigations and surveillance actions in Brazil.

Impact of COVID-19 Pandemic on Cancer-Related Hospitalizations in Brazil.

BACKGROUND: Alongside the SARS-CoV-2 (COVID-19) pandemic, Brazil also faces an ongoing rise in cancer burden. In 2020, there were approximately 592 000 new cancer cases and 260 000 cancer deaths. Considering the heterogeneities across Brazil, this study aimed to estimate the impact of the COVID-19 pandemic on cancer-related hospital admissions at a national and regional level. METHODS: The national, regional, and state-specific monthly average of cancer-related hospital admission rates per 100 000 inhabitants and 95% confidence intervals (95% CIs) were calculated from March to July (2019: pre-COVID-19; and 2020: COVID-19 period). Thematic maps were constructed to compare the rates between periods and regions. RESULTS: Cancer-related hospital admissions were reduced by 26% and 28% for clinical and surgical purposes, respectively. In Brazil, the average hospitalization rates decreased from 13.9 in 2019 to 10.2 in 2020 per 100,000 inhabitants, representing a rate difference of -3.7 (per 100,000 inhabitants; 95% CI: -3.9 to -3.5) for cancer-related (clinical) hospital admissions. Surgical hospital admissions showed a rate decline of -5.8 per 100,000 (95% CI: -6.0 to -5.5). The reduction in cancer-related admissions for the surgical procedure varies across regions ranging between -2.2 and -10.8 per 100 000 inhabitants, with the most significant decrease observed in the south and southeastern Brazil. CONCLUSIONS: We observed a substantial decrease in cancer-related hospital admissions during the COVID-19 pandemic with marked differences across regions. Delays in treatment may negatively impact cancer survival in the future; hence, cancer control strategies to mitigate the impact are needed.

The Capulana study: a prospective evaluation of cervical cancer screening using human papillomavirus testing in Mozambique.

BACKGROUND: Cervical cancer is the leading cause of cancer and related deaths among women in Mozambique. There is limited access to screening and few trained personnel to manage women with abnormal results. Our objective was to implement cervical cancer screening with human papillomavirus (HPV) testing, with navigation of women with abnormal results to appropriate diagnostic and treatment services. METHODS: We prospectively enrolled women aged 30-49 years living in Maputo, Mozambique, from April 2018 to September 2019. All participants underwent a pelvic examination by a nurse, and a cervical sample was collected and tested for HPV using the careHPV test (Qiagen, Gaithersburg, Maryland, USA). HPV positive women were referred for cryotherapy or, if ineligible for cryotherapy, a loop electrosurgical excision procedure. Women with findings concerning for cancer were referred to the gynecologic oncology service. RESULTS: Participants (n=898) had a median age of 38 years and 20.3% were women living with the human immunodeficiency virus. HPV positivity was 23.7% (95% confidence interval 21.0% to 26.6%); women living with human immunodeficiency virus were twice as likely to test positive for HPV as human immunodeficiency virus negative women (39.2% vs 19.9%, p<0.001). Most HPV positive women (194 of 213, 91.1%) completed all steps of their diagnostic work-up and treatment. Treatment included cryotherapy (n=158, 77.5%), loop electrosurgical excision procedure (n=30, 14.7%), or referral to a gynecologist or gynecologic oncologist (n=5, 2.5%). Of eight invasive cervical cancers, 5 (2.8%) were diagnosed in women living with human immunodeficiency virus and 3 (0.4%) in human immunodeficiency virus negative women (p=0.01). CONCLUSION: Cervical cancer screening with HPV testing, including appropriate follow-up and treatment, was feasible in our study cohort in Mozambique. Women living with human immunodeficiency virus appear to be at a significantly higher risk for HPV infection and the development of invasive cervical cancer than human immunodeficiency virus negative women.

HPV Vaccine: Updates and Highlights.

HPV is the most common sexually transmitted biological agent and is the cause of many conditions in men and women, including precancer lesions and cancer. Three prophylactic HPV vaccines targeting high-risk HPV types are available in many countries worldwide: 2-, 4- and 9-valent vaccines. All the 3 vaccines use recombinant DNA technology and are prepared from the purified L1 protein that self-assembles to form HPV type-specific empty shells. This non-systematic review aims to summarize the HPV epidemiology and the vaccine development to review the landmark trials of HPV vaccine, to present to most remarkable results from clinical trials and the real world, and to stress the challenges and the barriers for HPV vaccine implementation.

Microfluidic-Based Genosensor To Detect Human Papillomavirus (HPV16) for Head and Neck Cancer.

High-risk human papillomavirus (HPV) infection, mainly with HPV16 type, has been increasingly considered as an important etiologic factor in head and neck cancers. Detection of HPV16 is therefore crucial for these types of cancer, but clinical tests are not performed routinely in public health systems owing to the high cost and limitations of the existing tests. In this article, we report on a potentially low-cost genosensor capable of detecting low concentrations of HPV16 in buffer samples and distinguishing, with high accuracy, head and neck cancer cell lines according to their HPV16 status. The genosensor consisted of a microfluidic device that had an active layer of a HPV16 capture DNA probe (cpHPV16) deposited onto a layer-by-layer film of chitosan and chondroitin sulfate. Impedance spectroscopy was the principle of detection utilized, leading to a limit of detection of 10.5 pM for complementary ssDNA HPV16 oligos (ssHPV16). The genosensor was also able to distinguish among HPV16+ and HPV16- cell lines, using the multidimensional projection technique interactive document mapping. Hybridization between the ssHPV16 oligos and cpHPV16 probe was confirmed with polarization-modulated infrared reflection-absorption spectroscopy, where PO2 and amide I and amide II bands from adenine and thymine were monitored. The electrical response could be modeled as resulting from an adsorption process represented in a Freundlich model. Because the fabrication procedures of the microfluidic devices and genosensors and the data collection and analysis can be implemented at low cost, the results presented here amount to a demonstration of possible routine screening for HPV infections.

Pelvic radiotherapy for cervical cancer affects importantly the reproducibility of cytological alterations evaluation.

BACKGROUND: to evaluate the intraobserver and interobserver reproducibility of cervical cytopathology according to previous knowledge of whether patients received radiotherapy (RT) treatment or not. METHODS: The study analyzed a sample of 95 cervix cytological slides; 24 with cytological abnormalities (CA) and presence of RT; 21 without CA and presence of RT; 25 without CA and without previous RT; 25 with CA and without previous RT. Two cytopathology (CP) evaluations of the slides were carried out. For the first CP re-evaluation, the cytotechnologist was blinded for the information of previous RT. For the second CP re-evaluation, the cytotechnologist was informed about previous RT. The results were analyzed through inter and intraobserver agreement using the unweighted and weighted kappa. RESULTS: Post radiotherapy effects were identified in 44.4% of cases that undergone previous pelvic RT. The agreement for RT status was 66.32% (unweighted K = 0.31, 95%CI: 0.13; 0.49, moderate agreement). The intraobserver agreement, regarding the cytological diagnoses, regardless of radiotherapy status, was 80.32% (weighted K = 0.52, 95%CI: 0.34; 0.68). In no RT group, the intraobserver agreement was 70% (weighted K = 0.47, 95%CI: 0.27;0.65) and in patients that received RT, the intraobserver agreement was 84.09% (unweighted K = 0.37, 95%CI: 0.01;0.74). The interobserver agreement between cytopathology result (abnormal or normal) in the group with RT, considering normal and abnormal CP diagnosis was 14.0% and 12.5%, respectively. There was no association between the cytological alterations and the median time between the end of RT and the cytological diagnosis. CONCLUSION: This study showed that RT has an important impact in CP diagnosis because the agreement, also in interobserver and intraobserver analysis, had high discrepancy in patients that received RT. Also, demonstrated that it is difficult to recognize the presence of RT in cytological slides when this information is not provided.

A simple architecture with self-assembled monolayers to build immunosensors for detecting the pancreatic cancer biomarker CA19-9.

The challenge of the early diagnosis of pancreatic cancer in routine clinical practice requires low-cost means of detection, and this may be achieved with immunosensors based on electrical or electrochemical principles. In this paper, we report a potentially low-cost immunosensor built with interdigitated gold electrodes coated with a self-assembled monolayer and a layer of anti-CA19-9 antibodies, which is capable of detecting the pancreatic cancer biomarker CA19-9 using electrical impedance spectroscopy. Due to specific, irreversible adsorption of CA19-9 onto its corresponding antibody, according to data from polarization-modulated infrared reflection absorption spectroscopy (PM-IRRAS), the immunosensor is highly sensitive and selective. It could detect CA19-9 in commercial samples with a limit of detection of 0.68 U mL-1, in addition to distinguishing between blood serum samples from patients with different concentrations of CA19-9. Furthermore, by treating the capacitance data with information visualization methods, we were able to verify the selectivity and robustness of the immunosensor with regard to false positives, as the samples containing higher CA19-9 concentrations, including those from tumor cells, could be distinguished from those with possible interferents.

Role of P-selectin in thromboembolic events in patients with cancer.

The objective of the present study was to evaluate the role of P-selectin in patients with cancer with suspected thromboembolic events (TEEs). Patients with cancer have a four times greater risk of developing TEEs. P-selectin is a glycoprotein that has the function of facilitating the interaction (adhesion) of leukocytes with the endothelium, or with platelets. There is a well-defined relationship between P-selectin and thrombosis; however, it is likely that the cut-off value of P-selectin for patients with cancer should be considered differently from that of the general population. In the present report, a prospective cross-sectional study was performed with patients of the Cancer Hospital of Barretos who were suspected of having TEEs. Among the 178 study participants, 167 (93.82%) were suspected of having deep vein thrombosis, while 59 of them (35.33%) were confirmed as such; and 11 (6.18%) were suspected of having pulmonary thromboembolism, while 3 of them were confirmed as such (27.69%). The mean results obtained were: P-selectin, 25.37 ng/ml; and D-dimer, 2,181.22 ng/ml. The P-selectin levels averaged 33.60 ng/ml with the confirmed TEE group compared with 20.40 ng/ml with the unconfirmed TEE group, with a standard deviation of 23.35 compared with 6.92 (P<0.001); and the level of D-dimer was 4,615.38 ng/ml compared with 977.52 ng/ml, with a standard deviation of 6,460.54 compared with 2,145.50 (P<0.001). Multiple logistic regression adjusted for distant metastases and the Eastern Cooperative Oncology Group (ECOG) score (2,3 and 4) were constructed. The cut-off value of P-selectin for patients with cancer was identified to be different from that reported in the literature for the general population, and the models using D-dimer and P-selectin therefore have been demonstrated to be a potentially useful tool to be used in a panel of tests to predict TEEs, either independently or in a prediction score.

Characterization of topoisomerase II α and minichromosome maintenance protein 2 expression in anal carcinoma.

The present study aimed to ascertain the significance of topoisomerase II α (TOP2A) and minichromosome maintenance protein (MCM) 2 expression in anal carcinoma. A total of 75 anal lesions were retrieved from the files of the Department of Pathology of Barretos Cancer Hospital (Barretos, Brazil) in order to verify the human papillomavirus (HPV) statuses of these lesions and characterize the immunohistochemical expression levels of TOP2A and MCM2 in anal carcinoma, as these are important markers for cervical HPV-induced lesions; their expression was also compared with respect to p16 and Ki-67. The vast majority of the cases tested positive for HPV16 (84%); 1 case tested positive for both HPV16 and HPV18. Positive HPV16 status was more frequent in early stages than in advanced stages (P=0.008). Positive immunohistochemical reactivity for MCM2 and TOP2A protein was observed in 71.6 and 100% of cases, respectively. Positive reactivity for p16 was significantly associated (P=0.001) with histological grade, and was more commonly expressed in squamous cell carcinoma than adenocarcinomas. HPV16 was strongly associated with positive p16 protein expression (76.6%). However, the high expression of Ki-67 combined with the high expression of p16 was predominantly observed in Stage III-IV cases. MCM2, TOP2A, p16 and Ki-67 exhibited intense positive staining in the anal lesions, indicating that these markers were significantly and constantly expressed in anal carcinoma.

Analysis of Scanning Electron Microscopy Images To Investigate Adsorption Processes Responsible for Detection of Cancer Biomarkers.

Adsorption processes are responsible for detection of cancer biomarkers in biosensors (and immunosensors), which can be captured with various principles of detection. In this study, we used a biosensor made with nanostructured films of polypyrrole and p53 antibodies, and image analysis of scanning electron microscopy data made it possible to correlate morphological changes of the biosensor with the concentration of cells containing the cancer biomarker p53. The selectivity of the biosensor was proven by distinguishing images obtained with exposure of the biosensor to cells containing the biomarker from those acquired with cells that did not contain it. Detection was confirmed with cyclic voltammetry measurements, while the adsorption of the p53 biomarker was probed with polarization-modulated infrared reflection absorption (PM-IRRAS) and a quartz crystal microbalance (QCM). Adsorption is described using the Langmuir-Freundlich model, with saturation taking place at a concentration of 100 Ucells/mL. Taken together, our results point to novel ways to detect biomarkers or any type of analyte for which detection is based on adsorption as is the case of the majority of biosensors.

Immunosensor for Pancreatic Cancer Based on Electrospun Nanofibers Coated with Carbon Nanotubes or Gold Nanoparticles.

We report the fabrication of immunosensors based on nanostructured mats of electrospun nanofibers of polyamide 6 and poly(allylamine hydrochloride) coated either with multiwalled carbon nanotubes (MWCNTs) or gold nanoparticles (AuNPs), whose three-dimensional structure was suitable for the immobilization of anti-CA19-9 antibodies to detect the pancreatic cancer biomarker CA19-9. Using impedance spectroscopy, the sensing platform was able to detect CA19-9 with a detection limit of 1.84 and 1.57 U mL-1 for the nanostructured architectures containing MWCNTs and AuNPs, respectively. The high sensitivity achieved can be attributed to the irreversible adsorption between antibodies and antigens, as confirmed with polarization-modulated infrared reflection absorption spectroscopy. The adsorption mechanism was typical Langmuir-Freundlich processes. The high sensitivity and selectivity of the immunosensors were also explored in tests with blood serum from patients with distinct concentrations of CA19-9, for which the impedance spectra data were processed with a multidimensional projection technique. The robustness of the immunosensors in dealing with patient samples without suffering interference from analytes present in biological fluids is promising for a simple, effective diagnosis of pancreatic cancer at early stages.

Comparative analysis of basaloid and conventional squamous cell carcinomas of the esophagus: prognostic relevance of clinicopathological features and protein expression.

Basaloid squamous cell carcinoma (BSCC), a variant of squamous cell carcinoma (SCC), is a rare and aggressive epithelial malignancy which has been reported in only 0.1-11 % of primary esophageal carcinomas. In this study, a comparison of clinicopathological features and protein expression between esophageal BSCC (EBSCC) and conventional esophageal SCC (ESCC) cases from Brazil was performed in order to find factors that can be relevant to better characterize EBSCC. The expression of HER2, epidermal growth factor receptor (EGFR), Ki-67, and cyclins (A, B1, and D1) in 111 cases (95 ESCC and 16 EBSCC) was evaluated by immunohistochemistry using tissue microarray. When the clinicopathological data were compared, no significant difference was found between the two histological types. Although the difference is not significant (p = 0.055), the EGFR expression was more frequent in the conventional ESCC than in the EBSCC group. Our results indicate that the clinicopathological profiles of conventional ESCC and EBSCC are similar and provide no indicators for differences in prognosis between these two groups.

Clinical characteristics of women diagnosed with carcinoma who tested positive for cervical and anal high-risk human papillomavirus DNA and E6 RNA.

High-risk human papillomavirus (hrHPV) is an essential cause of cervical carcinoma and is also strongly related to anal cancer development. The hrHPV E6 oncoprotein plays a major role in carcinogenesis. We aimed to evaluate the frequency of hrHPV DNA and E6 oncoprotein in the anuses of women with cervical carcinoma. We analyzed 117 women with cervical cancer and 103 controls for hrHPV and the E6 oncogene. Positive test results for a cervical carcinoma included 66.7 % with hrHPV-16 and 7.7 % with hrHPV-18. One case tested positive for both HPV variants (0.9 %). The samples from the anal canal were positive for HPV-16 in 59.8 % of the cases. Simultaneous presence of HPV in the cervix and anal canal was found in 53.8 % of the cases. Regarding expression of E6 RNA, positivity for HPV-16 in the anal canal was found in 21.2 % of the cases, positivity for HPV-16 in the cervix was found in 75.0 %, and positivity for HPV-18 in the cervix was found in 1.9 %. E6 expression in both the cervix and anal canal was found in 19.2 % of the cases. In the controls, 1 % tested positive for HPV-16 and 0 % for HPV-18. Anal samples from the controls showed a hrHPV frequency of 4.9 % (only HPV16). The presence of hrHPV in the anal canal of women with cervical cancer was detected at a high frequency. We also detected E6 RNA expression in the anal canal of women with cervical cancer, suggesting that these women are at risk for anal hrHPV infection.

Cervicovaginal cytology in patients undergoing pelvic radiotherapy using the Focalpoint system: results from the RODEO study.

BACKGROUND: Evaluate the performance of the Focalpoint system in identifying and classifying cervical cytology alterations from samples collected from patients treated with Radiotherapy (RT). METHODS: The reproducibility of manual and automated screening by cytotechnologists using the BD Focalpoint GS Imaging System was examined. Samples were collected from May 2010 to August 2011. RESULTS: A total of 378 treated with RT and 8,967 cytology samples from patients without previous RT, were evaluated. The kappa values for cytological diagnoses read manually and automated in cases without previous RT were as follows: < ASC-H vs. ≥ ASC-H = 0.71; < LSIL vs. ≥ LSIL = 0.66; and < HSIL vs. ≥ HSIL = 0.67. The kappa for cytological diagnoses in post-RT women have showed: < ASC-H vs. ≥ ASC-H = 0.71; < LSIL vs. ≥ LSIL = 0.65; < HSIL vs. ≥ HSIL = 0.57. CONCLUSIONS: There was no significant difference among the kappa values we found. Post-RT cytology showed small diagnostic agreement between manual and automated examination. VIRTUAL SLIDES: The virtual slide(s) for this article can be found here: http://www.diagnosticpathology.diagnomx.eu/vs/13000_2014_231.

Prognostic scores after surgical treatment for cervical intraepithelial neoplasia: a proposed model and possible implications for post-operative follow-up.

OBJECTIVE: To develop a prognostic model for women who underwent surgical treatment for cervical intraepithelial neoplasia. DESIGN: Cohort study. Patient inclusion and follow-up occurred retrospectively and prospectively. SETTING: Barretos Cancer Hospital, Barretos, São Paulo, Brazil. POPULATION: Women (n = 242) diagnosed with cervical intraepithelial neoplasia who were submitted to conization. METHODS: Immediately prior to surgical treatment, a cervical cytology sample was collected from each individual included in the study by endocervical brushing and stored in a preservative solution with methanol. A human papilloma virus-DNA test was conducted using an aliquot of the endocervical brushings. The surgical specimens were subjected to immunohistochemical analysis of p16 (immunohistochemical analysis 4a) protein expression. MAIN OUTCOME MEASURES: Two-year disease-free survival rates calculated for each study variable. Identified variables in the multivariate Cox model were used for elaboration of prognostic scores. RESULTS: Variables associated with outcome included age (p = 0.033), tobacco use (p < 0.001), final histopathological diagnosis (p = 0.007), surgical margins (p < 0.001), high-risk human papilloma virus status (p = 0.008), human papilloma virus-16 status (p < 0.001) and immunoexpression of p16 in the cytoplasm (p = 0.049). By the Cox model, independent risk factors for disease recurrence/persistence were: tobacco use (hazard risk = 3.0; 95% confidence interval 1.6-5.6), positive surgical margins (hazard risk = 3.2; 95% confidence interval 1.6-6.1), human papilloma virus-16 (hazard risk = 3.3; 95% confidence interval 1.6-6.9) and age over 45 years (hazard risk = 2.7; 95% confidence interval 1.1-6.6). CONCLUSIONS: Establishment of a prognostic score can represent a valuable tool for determining the risk of cervical intraepithelial neoplasia recurrence after conization. The use of clinical (age and tobacco use), pathological (surgical margins) and molecular (human papilloma virus-16 genotyping) factors can facilitate more appropriate patient follow up according to risk stratification.

The significance of augmented high-grade squamous intraepithelial lesion detection on pap test examination: partial results from the RODEO study team.

OBJECTIVE: This study sought to ascertain the significance of augmented high-grade squamous intraepithelial lesion (HSIL) detection by Pap test using both conventional smear and liquid-based cytology (LBC) in a high-risk population. STUDY DESIGN: We conducted a direct-to-vial study to compare the diagnostic performance of Pap smear versus LBC in a high-risk population of women referred for colposcopy at a gynecologic ambulatory clinic at the Barretos Cancer Hospital in Brazil during 2011. RESULTS: The detection of both low-grade squamous intraepithelial lesions (LSILs) and HSILs was significantly greater (p = 0.04 and p = 0.033, respectively) in the LBC arm [84 LSIL cases (5.7%) and 148 HSIL cases (10.1%)] than in the conventional smear arm [66 LSIL cases (4.1%) and 126 HSIL cases (7.9%)]; however, no differences were found for invasive squamous carcinoma or adenocarcinoma (p = 0.678). Of 3,071 women who were examined cytologically (1,604 conventional preparations and 1,467 LBC) and colposcopically, biopsies were available for 279 conventional preparations (17.6%) and 325 LBC preparations (22.2%). No significant differences were found between the methods with respect to diagnostic performance. CONCLUSION: LBC was significantly superior to conventional smears for the detection of LSILs and HSILs, but these results did not influence biopsy confirmation. Both methods showed similar performances with high positive predictive values but very low sensitivities.

Performance and reproducibility of gynecologic cytology interpretation using the FocalPoint system: results of the RODEO Study Team.

OBJECTIVES: To assess whether automated screening in the cytologic examination of Papanicolaou smear slides results in smaller margins of error than manual screening. METHODS: We compared cytotechnologists' performance and reproducibility of manual and automated screening of 10,165 consecutive cervical cytology slides examined at Barretos Cancer Hospital using the FocalPoint system. RESULTS: In total, 83% of atypical squamous cells of undetermined significance and greater were classified as quintiles 1 and 2; no high-grade squamous intraepithelial lesions and greater were observed in quintile 5. No statistically significant differences were found between manual and automated screening, using cervical biopsy specimens as the gold standard. CONCLUSIONS: FocalPoint safely screened high-grade lesions, which can be valuable for high-workload routines.

Characterization of p16 and E6 HPV-related proteins in uterine cervix high-grade lesions of patients treated by conization with large loop excision.

Cervical cancer and its precursor lesions represent a significant public health problem for developing and less-developed countries. Cervical carcinogenesis is strongly correlated with persistent high-risk human papillomavirus (HPV) infection, which is mostly associated with expression of the p16 and E6 HPV-related proteins. The aim of this present study was to determine the expression of the p16 and E6 proteins in females with high-grade lesions treated with conization, and to discuss the role of these proteins as prognostic markers following treatment. In total, 114 females were treated for high-grade cervical intraepithelial neoplasia (CIN, grades 2/3) by conization with large loop excision of the transformation zone (LLETZ). Following surgery, the patients returned within 30-45 days for post-operative evaluation. A follow-up was conducted every 6 months for 2 years. At each follow-up appointment, a Pap smear, colposcopy and HPV DNA test were performed. E6 and p16 immunohistochemical tests were conducted on the surgical specimens. The positive expression of p16 was correlated with the presence of lesions with increased severity in the surgical specimens (P= 0.0001). The expression of E6 did not demonstrate the same correlation (P=0.131). The HPV DNA hybrid, collected in the first post-operative consultation as a predictor of the cytological abnormalities identified at the 24-month follow-up assessment, presented a sensitivity of 55.6%, a specificity of 84.8%, a positive predictive value of 33.3% and a negative predictive value of 93.3%. The role of p16INK4A as a marker of CIN was also demonstrated; the expression of p16 and E6, however, did not appear to be of any prognostic value in predicting the clearance of high-risk HPV following conization. A negative hybrid capture test was correlated with a disease-free outcome.

Self-collection for high-risk HPV detection in Brazilian women using the careHPV™ test.

OBJECTIVE: Cervical cancer is the second most common cancer among Brazilian women. High-risk human papillomavirus (hr-HPV) persistence is the primary cause of cervical neoplasia. Early detection of hr-HPV is important for identifying women at risk for developing cervical lesions. Approximately 85% of new cases of cervical cancer worldwide and 50% of the total cervical cancer deaths occurred in developing countries. Here, a new methodology to support a cervical cancer screening program was evaluated in women from various Brazilian regions. METHODS: Two thousand women aged 18-77 years were enrolled in an opportunistic cervical cancer screening program and were randomized into self-vaginal or health professional-guided cervical sampling groups. The Qiagen careHPV™ test was performed on all samples. Pap tests were performed on all women using liquid-based cytology. RESULTS: Positive hr-HPV results were obtained in 12.3% (245/2000) of women; similar rates were observed in self- or health professional-collected samples. Eighty-nine percent (1719/2000) of cervical cytologies classified as normal were negative to hr-HPV. Among the cytological samples, 36.6% classified as ASC-US+ were positive to hr-HPV, 78.8% were LSIL and 75.0% were HSIL. CONCLUSIONS: Self-sampled and health professional-sampled vaginal/cervical specimens did not differ in their rates of detection of hr-HPV. Therefore, HPV DNA testing in self-sampled vaginal cells is an alternative to primary screening in low-resource settings.

Could alarmingly high rates of negative diagnoses in remote rural areas be minimized with liquid-based cytology? Preliminary results from the RODEO Study Team.

OBJECTIVE: It was the aim of this study to compare diagnostic performances of the BD SurePath™ liquid-based Papanicolaou test (LBC) and the conventional Papanicolaou test (CPT) in cervical samples of women from remote rural areas of Brazil. STUDY DESIGN: Specimens were collected by mobile units provided by Barretos Cancer Hospital. This report evaluates the manual screening arm of the RODEO study. Of 12,048 women seen between May and December 2010, 6,001 were examined using LBC and 6,047 using CPT. RESULTS: Comparative (LBC vs. CPT) outcomes were: all abnormal tests, 2.1 versus 1.0%; ASC-US (atypical squamous cells of unknown significance), 0.7 versus 0.1%; ASC-H (atypical squamous cells with possible high-grade squamous intraepithelial lesions) and AGC (atypical glandular cells), 0.4 versus 0.3%; LSIL (low-grade squamous intraepithelial lesions), 0.7 versus 0.3%; HSIL (high-grade squamous intraepithelial lesions), 0.4 versus 0.2%, and unsatisfactory, 0.03 versus 0.08%. The LBC arm detected significantly more lesions (ASC-US+) than CPT (p < 0.001); however, when we divided the diagnoses into two groups, ASC-H- (negative/ASC-US/LSIL) and ASC-H+ (ASC-H/AGC/HSIL), the difference was not statistically important (p = 0.213). CONCLUSIONS: With inherent difficulties in patient recruitment and patient compliance with cancer screening, best test performance including human papillomavirus test capability are vitally necessary in Brazil's struggle to reduce cervical cancer.