Studying Lymph Nodes in Patients With Stage II Colon Cancer
Recruitment status was Recruiting
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.
Genetic: DNA analysis
Genetic: microarray analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: diagnostic laboratory biomarker analysis
Other: immunohistochemistry staining method
Procedure: regional lymph node dissection
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||Ultrastaging of Early Colon Cancer|
- Disease-free survival (time to local or distant recurrence after resection) [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||May 2009|
|Estimated Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949312
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA||Recruiting|
|Los Angeles, California, United States, 90095-1781|
|Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719|
|United States, District of Columbia|
|Walter Reed Army Medical Center||Recruiting|
|Washington, District of Columbia, United States, 20307-5001|
|Contact: Clinical Trials Office - Walter Reed Army Medical Center 202-782-7840|
|Principal Investigator:||Anton J. Bilchik, MD, PhD, FACS||Jonsson Comprehensive Cancer Center|