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

July 18, 2014 updated by: Forsyth Medical Center
The study will determine if adding fecal immunochemical testing (FIT) at yearly intervals to a colonoscopy screening program will improve colon cancer detection rates.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

4100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston Salem, North Carolina, United States, 27103
        • Active, not recruiting
        • Digestive Health Specialists, PA
      • Winston Salem, North Carolina, United States, 27103
      • Winston Salem, North Carolina, United States, 27103
        • Recruiting
        • Salem Gastroenterology Associates, PA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 Fecal Immunochemical Testing-Surveillance
Fecal Immunochemical Testing performed at yearly intervals.
Device: Fecal Immunochemical Testing
Fecal Immunochemical Testing is a stool test specific for human hemoglobin.
Other Names:
  • FIT
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.
Device: Fecal Immunochemical Testing
Fecal Immunochemical Testing is a stool test specific for human hemoglobin.
Other Names:
  • FIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
yearly

Secondary Outcome Measures

Outcome Measure
Time Frame
the pathology found at repeat colonoscopy in each group.
Time Frame: Yearly
Yearly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forsyth Medical Center

Investigators

  • Principal Investigator: Daniel Murphy, M.D., Piedmont Gastroenterology Specialists

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

May 1, 2019

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

May 1, 2009

First Submitted That Met QC Criteria

May 1, 2009

First Posted (Estimate)

May 4, 2009

Study Record Updates

Last Update Posted (Estimate)

July 21, 2014

Last Update Submitted That Met QC Criteria

July 18, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASC-FIT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe