Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients receive by mail the materials needed for stool samples.

Patients receive a personalized stimulus letter co-signed by their general practitioner and the medical coordinator of ADECA.

Co-signed Letter

No intervention (Patients receive by mail the materials needed for stool samples).

Control

Serge Gilberg

Barthe

The propose of this study is to assess the effect of general practitioner's involvement in the stimulus invitation letter in colorectal cancer screening compared to sending the patient home test (stimulus 2 of reference as contained in the specifications).

Does the Recall by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening?

Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening? A Cluster Randomised Controlled Study.

Increased number of patients who completed the test for faecal occult blood following the first solicitation with the letter co-signed by general practitioner, compared with the conventional solicition(including replies exclusions).

Adeca 75

Société de Formation Thérapeutique du Généraliste

Hotel Dieu Hospital

University of Paris 5 - Rene Descartes

Pr Serge Gilberg

Each patient will perform one guaiac and two immunochemical fecal occult blood tests at home.

fecal occult blood tests

The objective of this study is to compare the performance characteristics or accuracy of different in-home screening tests for colorectal cancer (fecal occult blood tests), among patients without symptoms of colorectal cancer. Patients who meet study eligibility criteria and agree to participate in the study are asked to perform one guaiac and two immunochemical fecal occult blood tests at home prior to their colonoscopy. After the patient has completed and sent in the test kits, the patient then undergoes their previously scheduled colonoscopy. Accuracy and performance characteristics for each type of fecal occult blood test, including sensitivity, specificity, test positivity rate and positive predictive value for advanced colorectal neoplasia (advanced colorectal polyps) or colorectal cancer, will be estimated by comparing the fecal occult blood test results with the results of the colonoscopy.

One of the recommended options for colorectal cancer screening in the population at average risk for colorectal cancer is annual fecal occult blood test (FOBT) starting at age 50. Randomized controlled trials have shown that annual or biennial fecal occult blood testing using a guaiac-based test reduces incidence and mortality from colorectal cancer. However, the sensitivity and specificity of the guaiac-based tests is relatively low. Guaiac-based fecal tests can produce false-positive or false-negative results with certain foods, vitamins, or medications, so dietary restrictions are generally recommended before the test. Newer, immunochemical FOBTs use antibodies to detect the globin portion of human hemoglobin and do not require dietary restrictions. These immunochemical tests may have improved performance characteristics (sensitivity and specificity) compared with the guaiac-based tests. However, there have been few studies of the performance characteristics of the immunochemical tests in the average-risk population, particularly for the iFOBTs that are currently available in the U.S. There are several iFOBT tests on the U.S. market which may have different performance characteristics.

Some of the newer immunochemical tests also have the advantage of having a simpler sampling procedure for the patient. Guaiac-based FOBTs generally use sticks or spatulas to collect specimens from three stools that have not contacted toilet bowl water; these specimens are then smeared on test cards. However, some immunochemical tests allow sample collection by brushing the surface of the stool while it is in the toilet bowl water. In addition, some immunochemical tests only require samples from one or two stools.

Colorectal cancer is a leading cause of cancer-related morbidity and mortality. Key policy groups including the ACS, the American College of Radiology, the U.S. Multi-society Task Force on Colorectal Cancer, and the U.S. Preventive Services Task Force recommend the FOBT (guaiac or immunochemical-based) as one of several appropriate screening strategies for colorectal cancer. Although colonoscopy has higher sensitivity and specificity than FOBT in detecting advanced colorectal neoplasia, colonoscopy is an invasive test that has several potential disadvantages when screening the average-risk population, including higher costs, capacity limitations, and increased risk of complications. Immunochemical FOBT may have some advantages over both guaiac-based FOBT and colonoscopy for screening the average-risk population, including better performance characteristics and better patient acceptability than gFOBT and lower costs than colonoscopy. Unfortunately, the scientific literature on the sensitivity and specificity of the respective tests is not sufficient to support more specific recommendations about which test is best for routine screening among asymptomatic adults. This study will address that crucial gap in the literature.

Study of In-home Tests for Colorectal Cancer

Performance Characteristics of Immunochemical and Guaiac FOBT

This outcome will assess the sensitivity of the fecal occult blood test for detection of advanced colorectal neoplasia. Advanced colorectal neoplasia will be defined as an adenoma with a diameter of 10 mm or more, a villous adenoma, a tubulovillous adenoma, an adenoma with high-grade dysplasia, carcinoma in situ, or invasive cancer. For each type of fecal occult blood test, the sensitivity for advanced colorectal neoplasia will be estimated by comparing the fecal occult blood test results with the results of the colonoscopy.

This outcome will assess the specificity of the fecal occult blood test for detection of advanced colorectal neoplasia. Advanced colorectal neoplasia will be defined as an adenoma with a diameter of 10 mm or more, a villous adenoma, a tubulovillous adenoma, an adenoma with high-grade dysplasia, carcinoma in situ, or invasive cancer. For each type of fecal occult blood test, the specificity for advanced colorectal neoplasia will be estimated by comparing the fecal occult blood test results with the results of the colonoscopy.

Battelle Memorial Institute

University of Minnesota

Indiana University

Park Nicollet Health Services

Centers for Disease Control and Prevention

Patients receive a personalized letter co-signed by their general practitioner and the medical coordinator of ADECA.

Co-signed letter

Patients receive classical letter signed by the coordinator doctor of ADECA

Classical Letter

The propose of this study is to assess the effect of general practitioner's involvement on first patients' solicitation in screening for colorectal cancer by testing for faecal occult blood (FOBT).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Does the Recall by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening?	NCT01279330	Colorectal Canc...	Co-signed Lette... Control	50 Years - 74 Years	University of Paris 5 - Rene Descartes
Study of In-home Tests for Colorectal Cancer	NCT01998009	Colorectal Canc...	fecal occult bl...	50 Years - 75 Years	Centers for Disease Control and Prevention
Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening?	NCT01279278	Colorectal Canc...	Co-signed lette... Classical Lette...	50 Years - 74 Years	University of Paris 5 - Rene Descartes

Spots Global Cancer Trial Database for fecal occult blood tests