RATIONALE: Diagnostic procedures that look for micrometastases in lymph nodes removed during surgery for colon cancer may help doctors learn the extent of disease. PURPOSE: This phase I trial is studying lymph nodes in patients with stage II colon cancer.
OBJECTIVES: * Determine whether the immunohistochemical and molecular presence of micrometastases in ≥ 12 lymph nodes removed during en-bloc resection in patients with stage II colon cancer correlates with 3-year disease-free survival. * Evaluate the prognostic significance of molecular markers detected in the primary tumor and develop a microarray-based gene signature for stage II colon cancer. OUTLINE: This is a multicenter study. Tumor tissue and regional lymph node samples are collected during surgery for analysis of micrometastases and molecular markers by immunohistochemistry, qRT-PCR, MM qRT-PCR, qRDNA-PCR, and microarray profiling. Patients are followed up periodically for 4 years after surgery.
Study Type
OBSERVATIONAL
Enrollment
26
John Wayne Cancer Institute
Santa Monica, California, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Disease-free survival (time to local or distant recurrence after resection)
The event to be used for DFS is time to recurrence (local or distant) after resection of colon cancer
Time frame: 48 months
Overall survival (time to death from colorectal cancer)
The event to be used for DFS is time to death after resection of colon cancer
Time frame: 48 months
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