A Prospective Randomized Study Comparing Sentinel Lymph Node (SLN) Evaluation With Standard Pathological Evaluation for the Staging of Colon Carcinoma
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|ClinicalTrials.gov Identifier: NCT01623258|
Recruitment Status : Completed
First Posted : June 19, 2012
Last Update Posted : June 19, 2012
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||34 participants|
|Study Start Date :||December 2002|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
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
- 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 ]
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): NCT01623258
|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|