Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing (ASC-FIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Forsyth Medical Center
Sponsor:
Information provided by (Responsible Party):
Forsyth Medical Center
ClinicalTrials.gov Identifier:
NCT00892593
First received: May 1, 2009
Last updated: July 18, 2014
Last verified: July 2014

May 1, 2009
July 18, 2014
May 2009
May 2019   (final data collection date for primary 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. [ Time Frame: yearly ] [ Designated as safety issue: No ]
rate of significant colon neoplasia among those who enter a surveillance program with FIT testing added at yearly intervals vs. that of "usual care" patients in the same patient population. [ Time Frame: yearly ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00892593 on ClinicalTrials.gov Archive Site
the pathology found at repeat colonoscopy in each group. [ Time Frame: Yearly ] [ Designated as safety issue: No ]
To describe the pathology found at repeat colonoscopy in both groups [ Time Frame: yearly ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing
Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing

The study will determine if adding fecal immunochemical testing (FIT) at yearly intervals to a colonoscopy screening program will improve colon cancer detection rates.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Colon Cancer
Device: Fecal Immunochemical Testing
Fecal Immunochemical Testing is a stool test specific for human hemoglobin.
Other Name: FIT
  • Experimental: 1 Fecal Immunochemical Testing-Surveillance
    Fecal Immunochemical Testing performed at yearly intervals.
    Intervention: Device: Fecal Immunochemical Testing
  • No Intervention: 2 Usual Care - Surveillance
  • No Intervention: 3 Usual Care - Screening
  • Experimental: 4 Fecal Immunochemical Testing-Screening
    Fecal Immunochemical Testing yearly, beginning at year 6.
    Intervention: Device: Fecal Immunochemical Testing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4100
May 2020
May 2019   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Debra W Norwood 336-718-6045 dwnorwood@novanthealth.org
Contact: Wendy L Hobbs 336-718-5808 wlhobbs@novanthealth.org
United States
 
NCT00892593
ASC-FIT
No
Forsyth Medical Center
Forsyth Medical Center
Not Provided
Principal Investigator: Daniel Murphy, M.D. Piedmont Gastroenterology Specialists
Forsyth Medical Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP