Clinical trial NCT00892593: Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing
Official title: Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Keywords: colon
neoplasia
polyp
adenoma
FIT
cancer
Lead sponsor: Forsyth Medical Center
Sponsor class: OTHER
First posted: 2009-05-04
Enrollment: 4100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: yearly
Secondary outcomes:
measure: the pathology found at repeat colonoscopy in each group.
timeFrame: Yearly
Other outcomes:
Locations:
city: Winston Salem
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Winston Salem
country: United States
facility: Piedmont Gastroenterology Specialists, PA
state: North Carolina
city: Winston Salem
country: United States
facility: Salem Gastroenterology Associates, PA
state: North Carolina
Study officials:
affiliation: Piedmont Gastroenterology Specialists
name: Daniel Murphy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: