Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing
Status unconfirmed · Not applicable
Conditions studied: Colon Cancer
In brief
The study will determine if adding fecal immunochemical testing (FIT) at yearly intervals to a colonoscopy screening program will improve colon cancer detection rates.
Key facts
- Study ID
- NCT00892593
- Run by
- Forsyth Medical Center
- People needed
- 4100
- Starts
- 2009-05-01
- Expected to finish
- 2020-05-01
- Last updated by the study team
- 2014-07-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Piedmont Gastroenterology Specialists, PA — Winston-Salem, North Carolina, United States (enrolling)
- Salem Gastroenterology Associates, PA — Winston-Salem, North Carolina, United States (enrolling)
- Digestive Health Specialists, PA — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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