Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing
This study will evaluate the benefit of augmenting a compliant College of Gastroenterology
colorectal cancer screening program with the addition of yearly FIT testing at two critical
points in the current recommended follow up: 1. In patients found to have adenomatous
polyps for the first time after colonoscopy, the addition of FIT in yearly intervals
following index colonoscopy and 2. For subjects with "clean" colonoscopies (no polyps
found), the addition of FIT at yearly intervals starting in year 6 and continuing to year 10
or subsequent colonoscopy. Current screening guidelines do not recommend the combination of
colonoscopy and FOBT.
Two factors plague an effective colon cancer screening program: 1) a less than 100%
sensitivity (95% ) for optical colonoscopy to detect colon cancer, and 2) Limitations of
guaiac based stool testing: low sensitivity ( 5% in single use) for detection of colon
cancer and the traditional gFOBT is cumbersome for patients to perform, impeding patient
acceptance and adherence.
FIT offers a FOBT with improved sensitivity (65% for invasive colon cancer) and improved
specificity and better patient compliance. The addition of FIT after initial colonoscopy
could be applied to a screening program and thereby salvage "missed" lesions by increased
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
rate of significant colon neoplasia among those who enter a screening or surveillance program with FIT testing added at yearly intervals vs. that of "usual care" patients in the same patient population.
Daniel Murphy, M.D.
Piedmont Gastroenterology Specialists
United States: Institutional Review Board
|Piedmont Gastroenterology Specialists, PA||Winston Salem, North Carolina 27103|
|Salem Gastroenterology Associates, PA||Winston Salem, North Carolina 27103|
|Digestive Health Specialists, PA||Winston Salem, North Carolina 27103|