Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing (ASC-FIT)
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Purpose
The study will determine if adding fecal immunochemical testing (FIT) at yearly intervals to a colonoscopy screening program will improve colon cancer detection rates.
| Condition | Intervention |
|---|---|
|
Colon Cancer |
Device: Fecal Immunochemical Testing |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing |
- 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 ] [ Designated as safety issue: No ]
- the pathology found at repeat colonoscopy in each group. [ Time Frame: Yearly ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 4100 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | May 2020 |
| Estimated Primary Completion Date: | May 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: FIT
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Richard C Evelyn | 336-277-0973 | rcevelyn@novanthealth.org |
| Contact: Wendy L Hobbs | 336-718-5808 | wlhobbs@novanthealth.org |
| United States, North Carolina | |
| Piedmont Gastroenterology Specialists, PA | Recruiting |
| Winston Salem, North Carolina, United States, 27103 | |
| Contact: Richard Evelyn 336-277-0973 rcevelyn@novanthealth.org | |
| Contact: Erica Habersham 336.277.0203 ehabersham@novanthealth.org | |
| Principal Investigator: Daniel Murphy, MD | |
| Salem Gastroenterology Associates, PA | Recruiting |
| Winston Salem, North Carolina, United States, 27103 | |
| Contact: Richard Evelyn 336-277-0973 rcevelyn@novanthealth.org | |
| Digestive Health Specialists, PA | Recruiting |
| Winston Salem, North Carolina, United States, 27103 | |
| Contact: Richard Evelyn 336-277-0973 rcevelyn@novanthealth.org | |
| Principal Investigator: | Daniel Murphy, M.D. | Piedmont Gastroenterology Specialists |
More Information
Additional Information:
No publications provided
| Responsible Party: | Forsyth Medical Center |
| ClinicalTrials.gov Identifier: | NCT00892593 History of Changes |
| Other Study ID Numbers: | ASC-FIT |
| Study First Received: | May 1, 2009 |
| Last Updated: | February 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Forsyth Medical Center:
|
colon neoplasia polyp |
adenoma FIT cancer |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013