A Prospective Randomized Study Comparing Sentinel Lymph Node (SLN) Evaluation With Standard Pathological Evaluation for the Staging of Colon Carcinoma
Completed
- Conditions
- Colon Cancer
- Registration Number
- NCT01623258
- Lead Sponsor
- Walter Reed Army Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
- 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
Exclusion Criteria
- Prior radiation or chemotherapy
- Non-palpable colon tumor
- Recurrent or Stage IV (metastatic) colon cancer
- Unable to give informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 1 day
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Walter Reed Army Medical Center
🇺🇸Washington DC, District of Columbia, United States