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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Walter Reed Army Medical Center

Fed

Registry information

Important dates

Study start: 2002
Primary completion: 2011
Study completion: 2011
First posted: Jun 19, 2012
Registry last updated: Jun 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed