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

Forsyth Medical Center

Status: Unknown

Conditions: Colon Cancer

Treatments: Device: Fecal Immunochemical Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT00892593

ASC-FIT

Details and patient eligibility

About

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

Full 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

Enrollment: 4,100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,100 participants in 4 patient groups

1 Fecal Immunochemical Testing-Surveillance

Experimental group

Description:

Fecal Immunochemical Testing performed at yearly intervals.

Treatment:

Device: Fecal Immunochemical Testing

Device: Fecal Immunochemical Testing

2 Usual Care - Surveillance

No Intervention group

3 Usual Care - Screening

No Intervention group

4 Fecal Immunochemical Testing-Screening

Experimental group

Description:

Fecal Immunochemical Testing yearly, beginning at year 6.

Treatment:

Device: Fecal Immunochemical Testing

Device: Fecal Immunochemical Testing