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ASC FIT

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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 »