Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing
NCT ID: NCT00892593
Last Updated: 2014-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
4100 participants
INTERVENTIONAL
2009-05-31
2020-05-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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1 Fecal Immunochemical Testing-Surveillance
Fecal Immunochemical Testing performed at yearly intervals.
Fecal Immunochemical Testing
Fecal Immunochemical Testing is a stool test specific for human hemoglobin.
2 Usual Care - Surveillance
No interventions assigned to this group
3 Usual Care - Screening
No interventions assigned to this group
4 Fecal Immunochemical Testing-Screening
Fecal Immunochemical Testing yearly, beginning at year 6.
Fecal Immunochemical Testing
Fecal Immunochemical Testing is a stool test specific for human hemoglobin.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Forsyth Medical Center
OTHER
Responsible Party
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Principal Investigators
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Daniel Murphy, M.D.
Role: PRINCIPAL_INVESTIGATOR
Piedmont Gastroenterology Specialists
Locations
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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, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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NovantHealthClinicalResearch/ASC-FIT
Other Identifiers
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ASC-FIT
Identifier Type: -
Identifier Source: org_study_id
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