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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexander Stojadinovic, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT01623258
First received: June 15, 2012
Last updated: June 18, 2012
Last verified: June 2012
  Purpose

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.


Condition
Colon Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: December 2002
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01623258

Locations
United States, District of Columbia
Walter Reed Army Medical Center
Washington DC, District of Columbia, United States, 20307-5001
Sponsors and Collaborators
Walter Reed Army Medical Center
Investigators
Principal Investigator: Alexander Stojadinovic Walter Reed Army Medical Center
  More Information

No publications provided by Walter Reed Army Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alexander Stojadinovic, Chief, Surgical Oncology, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT01623258     History of Changes
Other Study ID Numbers: 03-20010
Study First Received: June 15, 2012
Last Updated: June 18, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 28, 2014