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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA068485 | U.S. NIH Grant/Contract | View source | |
| VU-VICC-GI-0294 | |||
| VU-VICC-020603 | |||
| VU-VICC-020531 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Collecting and storing samples of tissue, blood, and other body fluids to test in the laboratory and gathering information about health and lifestyle from participants may help doctors learn more about cancer risk factors.
PURPOSE: This clinical trial is looking at biological, genetic, and lifestyle risk factors for developing colorectal adenomas or polyps in participants undergoing colonoscopy.
OBJECTIVES:
OUTLINE: Participants undergo screening colonoscopy and removal of any polyps.
Within 1 month of colonoscopy, participants undergo a 30-minute telephone interview and/or complete a mail survey to provide information on lifestyle and medical history that may be related to colorectal polyp risk. Participants who undergo removal of polyps during their colonoscopy also complete a 20-minute survey at their 3-year follow-up colonoscopy. Participants' medical records may also be reviewed.
Blood samples are collected at the time of colonoscopy. Some participants may also provide blood samples 1-2 weeks prior to colonoscopy. Tissue from the bisected portions of colorectal polyps > 5 mm in size that are removed during colonoscopy is also obtained. Some participants may also undergo normal colorectal tissue sample and saliva sample collection at the time of colonoscopy and urine sample collection 2 days prior to, during, and/or 8 weeks after colonoscopy.
Tissue samples may be stored for future genetic studies to evaluate genetic factors that may cause or be related to colon polyps or colorectal cancer.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biologic sample preservation procedure | Other | |||
| cytology specimen collection procedure | Other | |||
| medical chart review | Other | |||
| questionnaire administration | Other | |||
| survey administration | Other | |||
| biopsy | Procedure | |||
| evaluation of cancer risk factors | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment of 7,000 participants who are planning to undergo colonoscopy | ||
| Collection of questionnaires and medical records | ||
| Collection of biological samples, including urine, blood, buccal cells and/or saliva, rectal tissue, and colorectal polyps | ||
| Evaluation of risk factors and other differences between participants found to have polyps and those who do not have polyps |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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participants who are planning to undergo colonoscopy
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| Name | Affiliation | Role |
|---|---|---|
| Wei Zheng, MD, PhD, MPH | Vanderbilt-Ingram Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee | 37064 | United States | ||
| Vanderbilt-Ingram Cancer Center at Franklin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22277551 | Derived | Murff HJ, Shrubsole MJ, Cai Q, Smalley WE, Dai Q, Milne GL, Ness RM, Zheng W. Dietary intake of PUFAs and colorectal polyp risk. Am J Clin Nutr. 2012 Mar;95(3):703-12. doi: 10.3945/ajcn.111.024000. Epub 2012 Jan 25. |
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| screening colonoscopy | Procedure |
| Nashville |
| Tennessee |
| 37064 |
| United States |
| Veterans Affairs Medical Center - Nashville | Nashville | Tennessee | 37212 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D011230 | Precancerous Conditions |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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