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

NCT01623258 | Completed

• 1 other identifier: 03-20010
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard of Care

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

Research

SOC with sentinel lymph node analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Up to 150 male or female military healthcare beneficiaries over the age of 18 years presenting at the Walter Reed Army Medical Center (WRAMC) General Surgery clinic with the diagnosis of biopsy-proven, primary, non-metastatic (Clinical Stage I,II or III) colon carcinoma will be enrolled. Subjects with colonic masses clinically consistent with colon cancer, and eventually confirmed by pathology, will also be enrolled.

You may qualify if:

• 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

Sponsors & Collaborators

• Walter Reed Army Medical Center: lead

Study Sites (1)

Walter Reed Army Medical Center

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

Location

Related Publications (1)

• Nissan A, Protic M, Bilchik AJ, Howard RS, Peoples GE, Stojadinovic A. United States Military Cancer Institute Clinical Trials Group (USMCI GI-01) randomized controlled trial comparing targeted nodal assessment and ultrastaging with standard pathological evaluation for colon cancer. Ann Surg. 2012 Sep;256(3):412-27. doi: 10.1097/SLA.0b013e31826571c8.

  PMID: 22871988 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Alexander Stojadinovic

  Walter Reed Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Surgical Oncology

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: June 19, 2012
• Study Start: December 1, 2002
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: June 19, 2012

Record last verified: 2012-06

Locations

US (1)