Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing

  • STATUS
    Recruiting
  • participants needed
    4100
  • sponsor
    Forsyth Medical Center
Updated on 7 November 2020
screening colonoscopy
polypectomy

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

Details
Condition Malignant neoplasm of colon
Treatment Fecal Immunochemical Testing
Clinical Study IdentifierNCT00892593
SponsorForsyth Medical Center
Last Modified on7 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Group I (positive colonoscopy)
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)
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note