NCT00949312

Studying Lymph Nodes in Patients With Stage II Colon Cancer

Ultrastaging of Early Colon Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 26 (estimated)
• Sponsor: Saint John's Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-05-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2009-07-30
• Last updated: 2022-03-09

Locations

2 sites across 1 country: United States