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The primary objective of this study is to gather stool samples from subjects with inflammatory bowel disease (IBD) to be added to a test set of stool samples that will be utilized to help select molecular markers and determine the optimal sensitivity and specificity values for the Exact IBD-ACRN surveillance test for colorectal cancer (CRC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBD | Subjects will be men and women, 18-84 years of age, inclusive, who have been diagnosed with IBD. Each with a screening colonoscopy resulting in normal findings. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stool Collection Kit | Device | Stool Collection Kit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of the Exact CRC diagnostic screening test. | The primary endpoint is point estimates of the sensitivity of the diagnostic test for detection of colorectal cancer in IBD patients. | 15 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients are at risk of developing colorectal cancer at the time of their colonoscopy and the colonoscopy resulted in normal findings.
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| Name | Affiliation | Role |
|---|---|---|
| Graham Lidgard, PhD | Exact Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | United States | ||
| UC San Diego Medical Center |
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Provide anonymous, clinically characterized specimens for bio-repository for future colorectal cancer-related test development.
| La Jolla |
| California |
| 92093 |
| United States |
| Facey Medical Foundation | Mission Hills | California | 91345 | United States |
| Medical Research Center of Conneticut | Hamden | Connecticut | 06518 | United States |
| Edward Hines Jr. VA Hospital | Hines | Illinois | 60141 | United States |
| Gastroenterology Associates, LLC | Baton Rouge | Louisiana | 70809 | United States |
| Delta Research Partners | Monroe | Louisiana | 71201 | United States |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71103 | United States |
| Metropolitan Gastroenterology Group, PC Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| HealthEast Midway Clinic | Saint Paul | Minnesota | 55104 | United States |
| Gastrointestinal Associates | Jackson | Mississippi | 39202 | United States |
| AGA Clinical Research Associates, LLC | Egg Harbor TWP | New Jersey | 08234 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Asheville Gastroenterology Associates, PA | Asheville | North Carolina | 28801 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Kinston Medical Specialists, PA | Kinston | North Carolina | 28501 | United States |
| Digestive Health Specialists, PA | Winston-Salem | North Carolina | 27103 | United States |
| UC Health | Cincinnati | Ohio | 45267 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| Charlottesville Medical Research Center, LLC | Charlottesville | Virginia | 22911 | United States |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | United States |
| Blue Ridge Medical Research | Lynchburg | Virginia | 24502 | United States |
| University of Wisconsin Hospital & Clinics | Madison | Wisconsin | 53705 | United States |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53215 | United States |
| University of Calgary - Division of Gastroenterology | Calgary | Alberta | T2N1N4 | Canada |
| Winnipeg Regional Health Authority- Health Sciences | Winnipeg | Manitoba | R3A 1R9 | Canada |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D015179 | Colorectal Neoplasms |
| D004066 | Digestive System Diseases |
| D003108 | Colonic Diseases |
| D009369 | Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
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