Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing

Colon Cancer Clinical Trial

— ASC-FIT  

Official title:

Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00892593
• Other study ID #: ASC-FIT
• Status: Recruiting
• Phase: N/A
• First received: May 1, 2009
• Last updated: July 18, 2014
• Start date: May 2009
• Est. completion date: May 2020

Study information

• Verified date: July 2014
• Source: Forsyth Medical Center
• Contact: Debra W Norwood
• Phone: 336-718-6045
• Email: dwnorwood[@]novanthealth.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4100
• Est. completion date: May 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Device:
• Fecal Immunochemical Testing
Fecal Immunochemical Testing is a stool test specific for human hemoglobin.
• Fecal Immunochemical Testing
Fecal Immunochemical Testing is a stool test specific for human hemoglobin.

Locations

Country	Name	City	State
United States	Digestive Health Specialists, PA	Winston Salem	North Carolina
United States	Piedmont Gastroenterology Specialists, PA	Winston Salem	North Carolina
United States	Salem Gastroenterology Associates, PA	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Forsyth Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		yearly	No
Secondary	the pathology found at repeat colonoscopy in each group.		Yearly	No

External Links

•   NovantHealthClinicalResearch/ASC-FIT