Colon Cancer Clinical Trial
Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing
Summary
The study will determine if adding fecal immunochemical testing (FIT) at yearly intervals to a colonoscopy screening program will improve colon cancer detection rates.
Full Description
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 detection rates
Eligibility Criteria
Inclusion Criteria:
Group I (positive colonoscopy)
18 to 75 years of age
male or female
willing to provide written informed consent
In the event that the colonoscopy is incomplete, or polypectomy is partial, the above patients are eligible if a successful examination is completed within 6 months of the inadequate exam.
Group II (negative colonoscopy)
50 to 69 years of age
Male or female
Willing to provide written informed consent
In the event that the colonoscopy is incomplete, the patient is eligible if a successful examination is completed within 6 months of the inadequate exam.
Exclusion Criteria:
Group I (positive colonoscopy)
chronic use of coumadin
history of previous GI malignancy, inflammatory bowel disease (Crohns disease, ulcerative colitis)
age or health status contraindicates repeat colonoscopy
history of Familial Polyposis or Hereditary Nonpolyposis Colon Cancer Syndrome
The index colonoscopy resulted in a perforation requiring surgical repair
An otherwise qualifying colonoscopy is followed by a recommendation for repeat colonoscopy in ≤ 1 yr.
Group II (negative colonoscopy)
chronic use of coumadin
history of previous GI malignancy, inflammatory bowel disease (Crohns disease, ulcerative colitis)
age or health status contraindicates repeat colonoscopy
history of Familial Polyposis or Hereditary Nonpolyposis Colon Cancer Syndrome
The index colonoscopy resulted in a perforation requiring surgical repair
Significant family history resulting in a recommendation for repeat colonoscopy in 5 years or less
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There is 1 Location for this study
Winston Salem North Carolina, 27103, United States
Winston Salem North Carolina, 27103, United States More Info
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