Genetic Study of Young Patients With Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00044967
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 651
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival Up to 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (73)
Providence Cancer Center
🇺🇸Mobile, Alabama, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Arrowhead Regional Medical Center
🇺🇸Colton, California, United States
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Shands Cancer Center at the University of Florida Health Science Center
🇺🇸Gainesville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
Surgical Oncology of Northeast Georgia
🇺🇸Gainesville, Georgia, United States
Scroll for more (63 remaining)Providence Cancer Center🇺🇸Mobile, Alabama, United States