NCT00044967

Genetic Study of Young Patients With Colorectal Cancer

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 651 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
GENETIC	microsatellite instability analysis

Timeline

• Start date: 2002-05-01
• Primary completion: 2004-12-01
• Completion: 2004-12-01
• First posted: 2003-01-27
• Last updated: 2016-07-06

Locations

73 sites across 2 countries: United States, Canada