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Genetic Study of Young Patients With Colorectal Cancer

Completed
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
overall survivalUp to 2 years
Secondary Outcome Measures
NameTimeMethod

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

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Providence Cancer Center
🇺🇸Mobile, Alabama, United States
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