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

Walter Reed Army Medical Center

Status: Completed

Conditions: Colon Cancer

Study type: Observational

Funder types: Other U.S. Federal agency

Identifiers

NCT01623258

03-20010

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years of age
2. 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
3. Palpable mass at time of surgery
4. Capable of providing informed consent

Exclusion criteria

1. Prior radiation or chemotherapy
2. Non-palpable colon tumor
3. Recurrent or Stage IV (metastatic) colon cancer
4. Unable to give informed consent

Trial design

34 participants in 2 patient groups

Standard of Care

Description:

Standard histopathological evaluation using conventional paraffin embedding, sectioning and hematoxylin and eosin staining and microscopy without sentinel lymph node ultrastaging

Research

Description:

SOC with sentinel lymph node analysis