Genetic Study of Young Patients With Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Evaluate the prognostic significance (e.g., overall survival) of microsatellite instability (MSI) status in patients with early age-of-onset stage I-III colorectal cancer, assuming the presence of a quantitative interaction between MSI status and family history of cancer. Evaluate the development of metachronous neoplasms in this patient population. Evaluate the histologic features and genetic changes associated with hereditary nonpolyposis colorectal cancer in this patient population. 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.

Official Title
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A Prospective Study Of The Prognostic Significance Of Microsatellite Instability In Patients With Early Age-Of-Onset Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Genetic: microsatellite instability analysis


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of stage I-III adenocarcinoma of the colon or rectum Must have undergone an initial curative resection within the past year No colon or rectal cancer resection that does not allow for definitive T or N staging No initial post-surgical surveillance colonoscopy prior to study entry Must have a pathology specimen, with representative normal and tumor tissues, available for submission to the ACOSOG Central Specimen Bank prior to study entry No personal or family history of familial adenomatous polyposis No recurrent colorectal cancer PATIENT CHARACTERISTICS: Age 18 to 49 at first diagnosis Other Must be willing to provide a family cancer history to the study team and continue with follow-up colonoscopic surveillance No other malignancy within the past 5 years except completely resected cervical cancer or nonmelanoma skin cancer No evidence of recurrence of other prior malignancy PRIOR CONCURRENT THERAPY: Radiotherapy No prior pelvic radiotherapy for rectal cancer No concurrent preoperative pelvic radiotherapy for rectal cancer Surgery See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>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. | Genetic: microsatellite instability analysis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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