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| Name | Class |
|---|---|
| Uniformed Services University of the Health Sciences | FED |
| National Cancer Institute (NCI) | NIH |
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We hypothesized that aberrant crypt foci (ACF) are precursors of colon cancer; their prevention would correlate with cancer risk and their elimination would reduce that risk. In this study we wished to (1) establish the feasibility of stain-enhanced magnification colonoscopy, (2) determine whether colorectal cancer is asociated with increased numbers of ACF, and (3) investigate the natural history of ACF and the durability of their elimination.
Subjects are randomly assigned at the time of stain-enhanced magnification colonoscopy to have any ACF removed or merely observed. Subjects are evenly divided into those with and those without a personal history of colon cancer. ACF are tabulated by an observer blinded to the subject's personal history. All subjects are then re-evaluated after one year by an observer blinded to the original procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | All identified ACF eliminated by cold or hot colonoscopic biopsy forceps |
|
| 2 | Sham Comparator | ACF quantified and observed, re-evaluated after one year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical removal of ACF | Procedure | All ACF removed by either cold or hot colonoscopic biopsy forceps |
| |
| Measure | Description | Time Frame |
|---|---|---|
| number, size, and location of ACF identified | initially and after one year |
| Measure | Description | Time Frame |
|---|---|---|
| complications of stain-enhanced, magnification colonoscopy | initially and after one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter W. Soballe, M.D. | National Naval Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Naval Medical Center | Bethesda | Maryland | 20889 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17119054 | Result | Glebov OK, Rodriguez LM, Soballe P, DeNobile J, Cliatt J, Nakahara K, Kirsch IR. Gene expression patterns distinguish colonoscopically isolated human aberrant crypt foci from normal colonic mucosa. Cancer Epidemiol Biomarkers Prev. 2006 Nov;15(11):2253-62. doi: 10.1158/1055-9965.EPI-05-0694. | |
| 12917207 | Result |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Colonoscopic evaluation only |
| Procedure |
Stain-enhanced magnification endoscopy performed, ACF quantified at entry and after one year |
|
| Glebov OK, Rodriguez LM, Nakahara K, Jenkins J, Cliatt J, Humbyrd CJ, DeNobile J, Soballe P, Simon R, Wright G, Lynch P, Patterson S, Lynch H, Gallinger S, Buchbinder A, Gordon G, Hawk E, Kirsch IR. Distinguishing right from left colon by the pattern of gene expression. Cancer Epidemiol Biomarkers Prev. 2003 Aug;12(8):755-62. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |