Studying Lymph Nodes in Patients With Stage II Colon Cancer
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|ClinicalTrials.gov Identifier: NCT00949312|
Recruitment Status : Recruiting
First Posted : July 30, 2009
Last Update Posted : February 6, 2018
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.
|Condition or disease||Intervention/treatment|
|Colorectal Cancer||Genetic: RNA marker analysis of lymph node and primary tumors Genetic: microarray profiling of primary tumors Genetic: reverse transcriptase-polymerase chain reaction of lymph node specimens Other: diagnostic laboratory RNA and DNA biomarker analysis of primary tumors Procedure: regional lymph node dissection Other: lymph node staining for H&E and pancytokeratin IHC|
- 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|
|Estimated Enrollment :||300 participants|
|Official Title:||Ultrastaging of Early Colon Cancer|
|Actual Study Start Date :||May 2009|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
|Stage II unresected Colon Cancer||
Genetic: RNA marker analysis of lymph node and primary tumors
Genetic: microarray profiling of primary tumors
Genetic: reverse transcriptase-polymerase chain reaction of lymph node specimens
Other: diagnostic laboratory RNA and DNA biomarker analysis of primary tumors
Procedure: regional lymph node dissection
Other: lymph node staining for H&E and pancytokeratin IHC
- Disease-free survival (time to local or distant recurrence after resection) [ Time Frame: 48 months ]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 ]The event to be used for DFS is time to death after resection of colon cancer
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Erika Cobb 310-449-5206 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|