A Prospective Randomized Study Comparing Sentinel Lymph Node (SLN) Evaluation With Standard Pathological Evaluation for the Staging of Colon Carcinoma

Completed

Conditions studied: Colon Cancer

In brief

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.

Key facts

Study ID

NCT01623258

Run by

Walter Reed Army Medical Center

People needed

34

Starts

2002-12-01

Expected to finish

2011-08-01

Last updated by the study team

2012-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age
• Primary, non-metastatic [Stage I, II (localized, node negative), or III (localized, node positive)] colon carcinoma confirmed by tissue biopsy or colon mass clinically consistent with cancer and eventually confirmed by pathology
• Palpable mass at time of surgery
• Capable of providing informed consent

You may not qualify if…

• Prior radiation or chemotherapy
• Non-palpable colon tumor
• Recurrent or Stage IV (metastatic) colon cancer
• Unable to give informed consent

Where it is running

• Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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