Studying Lymph Nodes in Patients With Stage II Colon Cancer
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:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Ultrastaging of Early Colon Cancer|
- Disease-free survival (time to local or distant recurrence after resection) [ Time Frame: 48 months ] [ Designated as safety issue: No ]The event to be used for DFS is time to recurrence (local or distant) after resection of colon cancer
- Overall survival (time to death from colorectal cancer) [ Time Frame: 48 months ] [ Designated as safety issue: No ]The event to be used for DFS is time to death after resection of colon cancer
|Study Start Date:||May 2009|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
|No Intervention: IHC testing of Lymph Nodes||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|
- 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
|Contact: Anton J. Bilchik, MD, PhD, FACS||(310) 449-5206||bilchika@JWCI.org|
|United States, California|
|John Wayne Cancer Institute||Recruiting|
|Santa Monica, California, United States, 90404|
|Contact: Lisa van Kreuningen, M.S. 310-582-7053 firstname.lastname@example.org|
|Principal Investigator: Anton J. Bilchik, MD, PhD, FACS|
|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||John Wayne Cancer Institute|