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

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ClinicalTrials.gov Identifier: NCT01623258
Recruitment Status : Completed
First Posted : June 19, 2012
Last Update Posted : June 19, 2012
Sponsor:
Information provided by (Responsible Party):

June 15, 2012
June 19, 2012
June 19, 2012
December 2002
August 2011   (Final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
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A Prospective Randomized Study Comparing Sentinel Lymph Node (SLN) Evaluation With Standard Pathological Evaluation for the Staging of Colon Carcinoma
Not Provided

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
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.
Colon Cancer
Not Provided
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
August 2011
August 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01623258
03-20010
No
Not Provided
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Alexander Stojadinovic, Walter Reed Army Medical Center
Walter Reed Army Medical Center
Not Provided
Principal Investigator: Alexander Stojadinovic Walter Reed Army Medical Center
Walter Reed Army Medical Center
June 2012