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| Sponsors and Collaborators: |
American College of Surgeons National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00044967 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer |
Genetic: microsatellite instability analysis |
| Study Type: | Observational |
| Official Title: | A Prospective Study Of The Prognostic Significance Of Microsatellite Instability In Patients With Early Age-Of-Onset Colorectal Cancer |
| Study Start Date: | May 2002 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have undergone an initial curative resection within the past year
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Show 73 Study Locations| Study Chair: | Jose G. Guillem, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000069465, ACOSOG-Z0190 |
| Study First Received: | September 6, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00044967 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I colon cancer stage II colon cancer stage III colon cancer stage I rectal cancer |
stage II rectal cancer stage III rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum |
|
Digestive System Neoplasms Microsatellite Instability Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Rectal Neoplasm Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Adenocarcinoma Colorectal Neoplasms |
|
Digestive System Neoplasms Microsatellite Instability Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Neoplasms Pathologic Processes Neoplasms by Site Digestive System Diseases Genomic Instability Gastrointestinal Neoplasms Colorectal Neoplasms |