title: 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.
abstract: 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.
authors.affiliation: Gastroenterology Department, Rabin Medical Center, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Zohar
authors.initials: Z
authors.lastname: Levi
authors.forename: Shlomo
authors.initials: S
authors.lastname: Birkenfeld
authors.forename: Alex
authors.initials: A
authors.lastname: Vilkin
authors.forename: Micha
authors.initials: M
authors.lastname: Bar-Chana
authors.forename: Irena
authors.initials: I
authors.lastname: Lifshitz
authors.forename: Miri
authors.initials: M
authors.lastname: Chared
authors.forename: Eran
authors.initials: E
authors.lastname: Maoz
authors.forename: Yaron
authors.initials: Y
authors.lastname: Niv
mesh_terms: D000368:Aged; D015179:Colorectal Neoplasms / Q000175:diagnosis*; D005240:Feasibility Studies; D006138:Guaiac; D006801:Humans; D008875:Middle Aged; D009780:Occult Blood; D010349:Patient Compliance; D011446:Prospective Studies; D012042:Registries; D012680:Sensitivity and Specificity; D012923:Social Class
chemical_list: D006138:Guaiac