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Study Name/Number: ASC-FIT
Title: Augmentation of Screening Colonoscopy with Fecal Immunochemical Testing
Investigator: Daniel W. Murphy, MD
Purpose: this research will measure the impact of adding a stool test called Fecal Immunochemical Testing (FIT) to the recommended screening and colonoscopy program prescribed by a doctor. The goal is to enroll 4100 participants. This study will tell us if the addition of a yearly FIT test can improve our ability to detect and prevent precancerous and cancerous growths.
Eligibility:
Inclusion Criteria:
Group I (positive colonoscopy)
- Age 18 to 75
- 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 six months of the inadequate exam.
Group II (negative colonoscopy)
- Age 50 to 69
- 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 six months of the inadequate exam.
Exclusion Criteria:
Group 1 (positive colonoscopy)
- Chronic use of coumadin
- History of previous GI malignancy, inflammatory bowel disease (Crohn's 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 ≤ one year.
Group II (negative colonoscopy)
- Chronic use of coumadin
- History of previous GI malignancy, inflammatory bowel disease (Crohn's disease, ulcerative colotis)
- 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 five years or less.
Contact Information:
Erica Habersham
336-277-0203
Link to the current ClinicalTrials.gov record »