Studying Lymph Nodes in Patients With Stage II Colon Cancer
|ClinicalTrials.gov Identifier: NCT00949312|
Recruitment Status : Active, not recruiting
First Posted : July 30, 2009
Last Update Posted : June 17, 2019
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 :||26 participants|
|Official Title:||Ultrastaging of Early Colon Cancer|
|Actual Study Start Date :||May 2009|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
|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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949312
|United States, California|
|John Wayne Cancer Institute|
|Santa Monica, California, United States, 90404|
|United States, District of Columbia|
|Walter Reed Army Medical Center|
|Washington, District of Columbia, United States, 20307-5001|
|Principal Investigator:||Anton J. Bilchik, MD, PhD, FACS||John Wayne Cancer Institute|