Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening.

BACKGROUND: Colonoscopy and fecal immunochemical testing (FIT) are accepted strategies for colorectal-cancer screening in the average-risk population. METHODS: In this randomized, controlled trial involving asymptomatic adults 50 to 69 years of age, we compared one-time colonoscopy in 26,703 subjects with FIT every 2 years in 26,599 subjects. The primary outcome was the rate of death from colorectal cancer at 10 years. This interim report describes rates of participation, diagnostic findings, and occurrence of major complications at completion of the baseline screening. Study outcomes were analyzed in both intention-to-screen and as-screened populations. RESULTS: The rate of participation was higher in the FIT group than in the colonoscopy group (34.2% vs. 24.6%, P<0.001). Colorectal cancer was found in 30 subjects (0.1%) in the colonoscopy group and 33 subjects (0.1%) in the FIT group (odds ratio, 0.99; 95% confidence interval [CI], 0.61 to 1.64; P=0.99). Advanced adenomas were detected in 514 subjects (1.9%) in the colonoscopy group and 231 subjects (0.9%) in the FIT group (odds ratio, 2.30; 95% CI, 1.97 to 2.69; P<0.001), and nonadvanced adenomas were detected in 1109 subjects (4.2%) in the colonoscopy group and 119 subjects (0.4%) in the FIT group (odds ratio, 9.80; 95% CI, 8.10 to 11.85; P<0.001). CONCLUSIONS: Subjects in the FIT group were more likely to participate in screening than were those in the colonoscopy group. On the baseline screening examination, the numbers of subjects in whom colorectal cancer was detected were similar in the two study groups, but more adenomas were identified in the colonoscopy group. (Funded by Instituto de Salud Carlos III and others; ClinicalTrials.gov number, NCT00906997.).

Exocrine pancreatic cancer clinical factors were related to timing of blood extraction and influenced serum concentrations of lipids.

OBJECTIVE: Disease-induced changes in blood concentrations of lipids may bias etiologic studies. We analyzed the influence of clinical factors and timing of blood extraction on serum concentrations of cholesterol and triglycerides in exocrine pancreatic cancer (EPC). STUDY DESIGN AND SETTING: Subjects were 144 incident cases of EPC prospectively recruited in five teaching hospitals in eastern Spain. RESULTS: Higher concentrations of cholesterol, triglycerides, and total lipids were observed among patients with a shorter interval from first symptom of cancer to blood extraction (IES); but concentrations were lower in patients with longer IES. The relationship between cholesterol and tumor stage was "n-shaped." Jaundice and other components of the cholestatic syndrome increased cholesterol and triglycerides. Invasive diagnostic tests were associated with lower cholesterol. All these factors were related to changes >50mg/dl in cholesterol (P<0.05), even when adjusting by stage. Statistical models including IES, number of invasive diagnostic tests, jaundice, weight loss, and stage explained over 28% of the variation in lipid concentrations. CONCLUSION: Restriction and adjustment by stage may be insufficient to prevent biases related to disease progression. Multivariate analyses may allow to control to some extent the influence of clinical symptoms, procedures, and timing of blood extraction in studies on the etiological significance of lipids and lipophilic compounds, either risk factors or protective agents.

Timing of blood extraction in epidemiologic and proteomic studies: results and proposals from the PANKRAS II Study.

There are no consensus guidelines or standards for epidemiologic and '-omics' studies using blood biomarkers on how to report the timing of extraction of blood samples. However, disease-induced changes in blood concentrations of exogenous and endogenous compounds may bias studies. The aim of the present report is to describe the timing of blood collection with respect to a variety of relevant clinical events in the PANKRAS II Study, and to suggest ways to display graphically the quantitative information. Subjects were 167 incident cases of exocrine pancreatic cancer prospectively recruited in five teaching hospitals in eastern Spain. Over 80% of patients had blood extracted during the first 6 months since onset of cancer symptoms, and 82% within the first month of admission to a study hospital. Over 80% of cases had blood drawn after an ultrasound, a CT scan or an ERCP, 25% after a laparotomy, and 37% after treatment onset. All three intervals from blood extraction to diagnosis, to treatment onset and to interview had a median of 0 days, and 88% of cases had blood drawn within 2 weeks of diagnosis. Over 72% of cases had concentrations of total lipids in the medium, normal range. Results suggest ways to report intervals involving blood biomarkers and may contribute to develop consensus guidelines and standards on the collection of blood samples in epidemiologic and '-omics' research.