A Prospective Randomized Study Comparing Sentinel Lymph Node (SLN) Evaluation With Standard Pathological Evaluation for the Staging of Colon Carcinoma
The objective of this trial is to define the rate of upstaging of colon carcinoma lymph node metastasis with sentinel lymph node (SLN) mapping.
Null hypothesis: There is no difference in the rate of lymph node metastasis between conventional histopathological processing of lymph nodes and SLN mapping with detailed pathologic examination using immunohistochemistry (IHC) in patients undergoing resection of colon carcinoma.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
- Define the rate of upstaging of colon carcinoma lymph node metastasis with define the rate of upstaging of colon carcinoma lymph node metastasis with sentinel lymph node (SLN) mapping [ Time Frame: 1 day ] [ Designated as safety issue: No ]
|Study Start Date:||December 2002|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Standard of Care
Standard histopathological evaluation using conventional paraffin embedding, sectioning and hematoxylin and eosin staining and microscopy without sentinel lymph node ultrastaging
SOC with sentinel lymph node analysis
|United States, District of Columbia|
|Walter Reed Army Medical Center|
|Washington DC, District of Columbia, United States, 20307-5001|
|Principal Investigator:||Alexander Stojadinovic||Walter Reed Army Medical Center|