Status:
UNKNOWN
Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing
Lead Sponsor:
Forsyth Medical Center
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed 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 cur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
4100 Patients enrolled
Trial Details
Trial ID
NCT00892593
Start Date
May 1 2009
End Date
May 1 2020
Last Update
July 21 2014
Active Locations (3)
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1
Digestive Health Specialists, PA
Winston-Salem, North Carolina, United States, 27103
2
Piedmont Gastroenterology Specialists, PA
Winston-Salem, North Carolina, United States, 27103
3
Salem Gastroenterology Associates, PA
Winston-Salem, North Carolina, United States, 27103