Spots Global Cancer Trial Database for Studying Lymph Nodes in Patients With Stage II Colon Cancer

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Trial Identification

Brief Title: Studying Lymph Nodes in Patients With Stage II Colon Cancer

Official Title: Ultrastaging of Early Colon Cancer

Study ID: NCT00949312

Conditions

Colorectal Cancer

Interventions

RNA marker analysis of lymph node and primary tumors

microarray profiling of primary tumors

reverse transcriptase-polymerase chain reaction of lymph node specimens

diagnostic laboratory RNA and DNA biomarker analysis of primary tumors

regional lymph node dissection

lymph node staining for H&E and pancytokeratin IHC

Study Description

Brief Summary: 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.

Detailed Description: 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.