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The purpose if this study is to measure the sensitivity, specificity and accuracy of the Metabiomics Colon Polyp and Colorectal Cancer Assay for the non-invasive detection of colon polyps or colorectal cancer.
The purpose of this study is to conduct clinical research to investigate the association of the gut microbiome with colonic neoplasia. In this study patients will supply samples of their gut microbiome prior to scheduled colonoscopy; the relative abundance of microbes from those samples will be used to predict the presence or absence of colon polyps or colorectal cancer. Microbiome based predictions from blinded samples will be compared with colonoscopy and pathology results to quantify the sensitivity, specificity and accuracy (reported as %) of the Metabiomics Colon Polyp and Colorectal Cancer Assay for colon polyps. The limited sample size is anticipated to be insufficient to quantify sensitivity to colorectal cancer.
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| Measure | Description | Time Frame |
|---|---|---|
| Performance of Metabiomics Colon Polyp and Colorectal Cancer Assay | Microbiome based predictions from at least 100 blinded samples will be compared with colonoscopy and pathology results to quantify the sensitivity, specificity and accuracy (reported as %) of the Metabiomics Colon Polyp and Colorectal Cancer Assay for colon polyps. The limited sample size is anticipated to be insufficient to quantify sensitivity to colorectal cancer. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients at average risk of developing colorectal cancer, scheduled for colonoscopy.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Hardi, M.D. | Metropolitan Gastroenterology Group | Principal Investigator |
| Louis Korman, M.D. | Metropolitan Gastroenterology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DC Endoscopy Center | Washington D.C. | District of Columbia | 20006 | United States | ||
| Chevy Chase Endoscopy Center |
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| Label | URL |
|---|---|
| Click here for more information about the sponsor of this study, Metabiomics. | View source |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009369 | Neoplasms |
| D003110 | Colonic Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D003108 | Colonic Diseases |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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gut microbiome samples from stool, rectal and colonic mucosa
| Chevy Chase |
| Maryland |
| 20815 |
| United States |