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Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing


N/A
18 Years
N/A
Open (Enrolling)
Both
Colon Cancer

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Trial Information

Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing


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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

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.

Outcome Time Frame:

yearly

Safety Issue:

No

Principal Investigator

Daniel Murphy, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Piedmont Gastroenterology Specialists

Authority:

United States: Institutional Review Board

Study ID:

ASC-FIT

NCT ID:

NCT00892593

Start Date:

May 2009

Completion Date:

May 2020

Related Keywords:

  • Colon Cancer
  • colon
  • neoplasia
  • polyp
  • adenoma
  • FIT
  • cancer
  • Colonic Neoplasms

Name

Location

Piedmont Gastroenterology Specialists, PAWinston Salem, North Carolina  27103
Salem Gastroenterology Associates, PAWinston Salem, North Carolina  27103
Digestive Health Specialists, PAWinston Salem, North Carolina  27103