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| Descriptive Information Fields | |||||
| Brief Title † | Genetic Study of Young Patients With Colorectal Cancer | ||||
| Official Title † | A Prospective Study Of The Prognostic Significance Of Microsatellite Instability In Patients With Early Age-Of-Onset Colorectal Cancer | ||||
| Brief Summary | RATIONALE: Identifying gene mutations (microsatellite instability) may allow doctors to plan effective treatment for patients who develop colorectal cancer at an early age. PURPOSE: Genetic trial to determine the significance of gene mutations in helping predict the outcome of treatment in patients who develop stage I, stage II, or stage III colorectal cancer at an early age. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to family history using the Amsterdam II criteria for hereditary nonpolyposis colorectal cancer (positive vs negative). Patients undergo baseline colonoscopy before or within 6 months of initial curative resection and then surveillance colonoscopy at 1, 3, and 5 years (+/- 6 months) after resection. The number, size, location, histology, and method of removal of polyps are documented at the time of colonoscopy. Patients also undergo microsatellite instability (MSI) status testing and complete family history questionnaires at baseline. The prognostic significance of family history and MSI status is evaluated. The individual histologic features of the tumors are compared with the MSI status to determine their predictive value. The histologic features are also correlated with outcome to determine their prognostic significance. Patients may be referred for genetic counseling. A certificate of confidentiality protecting the identity of research participants in this project has been issued by the National Cancer Institute. PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 6 years. |
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| Study Phase | |||||
| Study Type † | Observational | ||||
| Study Design † | |||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Colorectal Cancer | ||||
| Intervention † | Procedure: microsatellite instability analysis | ||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | |||||
| Start Date † | May 2002 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Gender | Both | ||||
| Ages | 18 Years to 49 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States, Canada | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00044967 | ||||
| Organization ID | CDR0000069465 | ||||
| Secondary IDs †† | ACOSOG-Z0190 | ||||
| Study Sponsor † | American College of Surgeons | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | October 2004 | ||||
| First Received Date † | September 6, 2002 | ||||
| Last Updated Date | August 29, 2008 | ||||