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The study will determine if adding fecal immunochemical testing (FIT) at yearly intervals to a colonoscopy screening program will improve colon cancer detection rates.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Fecal Immunochemical Testing-Surveillance | Experimental | Fecal Immunochemical Testing performed at yearly intervals. |
|
| 2 Usual Care - Surveillance | No Intervention | ||
| 3 Usual Care - Screening | No Intervention | ||
| 4 Fecal Immunochemical Testing-Screening | Experimental | Fecal Immunochemical Testing yearly, beginning at year 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Immunochemical Testing | Device | Fecal Immunochemical Testing is a stool test specific for human hemoglobin. |
|
| Measure | Description | 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. | yearly |
| Measure | Description | Time Frame |
|---|---|---|
| the pathology found at repeat colonoscopy in each group. | Yearly |
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Inclusion Criteria:
Group I (positive colonoscopy)
Group II (negative colonoscopy)
Exclusion Criteria:
Group I (positive colonoscopy)
Group II (negative colonoscopy)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Debra W Norwood | Contact | 336-718-6045 | dwnorwood@novanthealth.org | |
| Wendy L Hobbs | Contact | 336-718-5808 | wlhobbs@novanthealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Murphy, M.D. | Piedmont Gastroenterology Specialists | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Health Specialists, PA | Active, not recruiting | Winston-Salem | North Carolina | 27103 | United States | |
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| Label | URL |
|---|---|
| NovantHealthClinicalResearch/ASC-FIT | View source |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D009369 | Neoplasms |
| D011127 | Polyps |
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Fecal Immunochemical Testing | Device | Fecal Immunochemical Testing is a stool test specific for human hemoglobin. |
|
|
| Piedmont Gastroenterology Specialists, PA |
| Recruiting |
| Winston-Salem |
| North Carolina |
| 27103 |
| United States |
|
| Salem Gastroenterology Associates, PA | Recruiting | Winston-Salem | North Carolina | 27103 | United States |
|
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |