- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00892593
Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing (ASC-FIT)
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Debra W Norwood
- Phone Number: 336-718-6045
- Email: dwnorwood@novanthealth.org
Study Contact Backup
- Name: Wendy L Hobbs
- Phone Number: 336-718-5808
- Email: wlhobbs@novanthealth.org
Study Locations
-
-
North Carolina
-
Winston Salem, North Carolina, United States, 27103
- Active, not recruiting
- Digestive Health Specialists, PA
-
Winston Salem, North Carolina, United States, 27103
- Recruiting
- Piedmont Gastroenterology Specialists, PA
-
Contact:
- Erica Habersham
- Phone Number: 336-277-0203
- Email: ehabersham@novanthealth.org
-
Contact:
- Kyeshia Robinson
- Phone Number: 336.718-5813
- Email: kyeshia.robinson@novanthealth.org
-
Principal Investigator:
- Daniel Murphy, MD
-
Winston Salem, North Carolina, United States, 27103
- Recruiting
- Salem Gastroenterology Associates, PA
-
Contact:
- Erica Habersham
- Phone Number: 336-277-0203
- Email: ehabersham@novanthealth.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
Fecal Immunochemical Testing is a stool test specific for human hemoglobin.
Other Names:
|
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.
|
Fecal Immunochemical Testing is a stool test specific for human hemoglobin.
Other Names:
|
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
Sponsor
Investigators
- Principal Investigator: Daniel Murphy, M.D., Piedmont Gastroenterology Specialists
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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.
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