Lymphatic Mapping, Sentinel Lymph Node Analysis, and Blood Tests in Detecting and Predicting Early Micrometastases in Patients With Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00625625|
Recruitment Status : Unknown
Verified February 2008 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : February 28, 2008
Last Update Posted : September 17, 2013
RATIONALE: Diagnostic procedures, such as lymph node mapping during surgery and sentinel lymph node biopsy, may help doctors find micrometastases and predict cancer recurrence.
PURPOSE: This phase II trial is studying how well lymph node mapping during surgery together with sentinel lymph node analysis and blood testing work in detecting and predicting early micrometastases in patients with colorectal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: isosulfan blue Genetic: polymerase chain reaction Other: diagnostic laboratory biomarker analysis Other: immunohistochemistry staining method Procedure: diagnostic lymphadenectomy Procedure: therapeutic conventional surgery Procedure: therapeutic lymphadenectomy||Phase 2|
- To determine the accuracy and sensitivity of intraoperative lymph node mapping with isosulfan blue and sentinal node biopsy (SLN) in patients with colorectal cancer (CRC).
- To compare molecular and immunohistochemical methods for detection of micrometastases in the SLN and primary tumor and evaluate the clinical outcome.
- To evaluate the clinicopathological utility of hematogenous micrometastases in predicting disease recurrence in CRC.
OUTLINE: Patients receive isosulfan blue subserosally around the primary tumor for sentinel lymph node (SLN) identification and SLN(s) are marked. Patients undergo a standard colon resection as planned to include the SLN(s) and regional lymph nodes.
Lymph nodes removed during surgery are analyzed within 30 days after surgery. Routine pathologic analysis (H&E) are performed on all lymph nodes (SLN and non-SLN) removed. Immunohistochemical (IHC) staining for cytokeratin antibodies AE-1/AE-3 or MAK-6 are performed on all lymph nodes negative by H&E. Multimarker PCR (MM PCR) are performed on all SLNs. Blood samples are collected at baseline and then periodically for 4 years for MM PCR to detect circulating tumor cells and standard tumor markers (e.g., CEA).
After surgery, patients are followed every 6 months for 4 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||225 participants|
|Official Title:||Ultrastaging of Early Cancer of the Large Bowel Using Intraoperative Lymphatic Mapping, Sentinel Node Analysis and Blood Testing|
|Study Start Date :||March 2004|
|Estimated Primary Completion Date :||November 2007|
- Sensitivity and accuracy of lymphatic mapping in colorectal cancer
- Overall survival
- Disease-free survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625625
|OverallOfficial:||Shamim Baker||John Wayne Cancer Institute|