Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing
18 Years
N/A
Both
Colon Cancer
Trial Information
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
detection rates
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Outcome Measure:
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.
Outcome Time Frame:
yearly
Safety Issue:
No
Principal Investigator
Daniel Murphy, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Piedmont Gastroenterology Specialists
Authority:
United States: Institutional Review Board
Study ID:
ASC-FIT
NCT ID:
NCT00892593
Start Date:
May 2009
Completion Date:
May 2020
Related Keywords:
- Colon Cancer
- colon
- neoplasia
- polyp
- adenoma
- FIT
- cancer
- Colonic Neoplasms
Name | Location |
|---|---|
| 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 |
