A higher detection rate for colorectal cancer and advanced adenomatous polyp for screening with immunochemical fecal occult blood test than guaiac fecal occult blood test, despite lower compliance rate. A prospective, controlled, feasibility study

• Published in: International journal of cancer 2011-05, Vol.128 (10), p.2415-2424
• Main Authors: Levi, Zohar, Birkenfeld, Shlomo, Vilkin, Alex, Bar‐Chana, Micha, Lifshitz, Irena, Chared, Miri, Maoz, Eran, Niv, Yaron
• Format: Article
• Language: English
• Subjects: Aged; Biological and medical sciences; Blood; Blood tests; Cancer; Colon; Colorectal cancer; Colorectal carcinoma; Colorectal Neoplasms - diagnosis; Confidence intervals; Feasibility Studies; fecal occult blood test; Feces; FIT; Gastroenterology. Liver. Pancreas. Abdomen; Guaiac; G‐FOBT; Home medical tests; Humans; immunochemical test; Medical research; Medical sciences; Middle Aged; Occult Blood; Patient Compliance; Prospective Studies; Registries; screening; sensitivity; Sensitivity and Specificity; Social Class; Socioeconomic factors; Socioeconomics; specificity; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Tumors; Urban populations
• ISSN: 0020-7136; 1097-0215; 1097-0215
• DOI: 10.1002/ijc.25574

Immunochemical fecal occult blood test (FIT) is a new colorectal cancer (CRC) screening method already recommended by the American screening guidelines. We aimed to test the feasibility of FIT as compared to guaiac fecal occult blood test (G‐FOBT) in a large urban population of Tel Aviv. Average‐risk persons, aged 50–75 years, were offered FIT or G‐FOBT after randomization according to the socioeconomic status of their clinics. Participants with positive tests underwent colonoscopy. Participants were followed through the Cancer Registry 2 years after the study. Hemoccult SENSA™ and OC‐MICRO™ (three samples, 70 ng/ml threshold) were used. FIT was offered to 4,657 persons (Group A) and G‐FOBT to 7,880 persons (Group B). Participation rate was 25.9% and 28.8% in Group A and B, respectively (p < 0.001). Positivity rate in Group A and B was 12.7% and 3.9%, respectively (p < 0.001). Cancer found in six (0.49%) and eight (0.35%) patients of Group A and B, respectively (NS). Cancer registry follow‐up found missed cancer in five (0.22%) cases of Group B and none in Group A (NS). The sensitivity, specificity, negative and positive predictive value for cancer in Group A and B were 100%, 85.9%, 100%, 3.9% and 61.5%, 96.4%, 99.8%, 9.1%, respectively. There was increased detection of advanced adenomatous polyp (AAP) by FIT, irrespective of age, gender, and socioeconomic status (Per Protocol: odds ratio 2.69, 95% confidence interval 1.6–4.5; Intention to Screen: odds ratio 3.16, 95% confidence interval 1.8–5.4). FIT is feasible in urban, average‐risk population, which significantly improved performance for detection of AAP and CRC, despite reduced participation.