A Prospective Randomized Study Comparing Sentinel Lymph Node (SLN) Evaluation With Standard Pathological Evaluation for the Staging of Colon Carcinoma
NCT ID: NCT01623258
Last Updated: 2012-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
34 participants
OBSERVATIONAL
2002-12-31
2011-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standard of Care
Standard histopathological evaluation using conventional paraffin embedding, sectioning and hematoxylin and eosin staining and microscopy without sentinel lymph node ultrastaging
No interventions assigned to this group
Research
SOC with sentinel lymph node analysis
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
2. Non-palpable colon tumor
3. Recurrent or Stage IV (metastatic) colon cancer
4. Unable to give informed consent
18 Years
ALL
No
Sponsors
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Walter Reed Army Medical Center
FED
Responsible Party
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Alexander Stojadinovic
Chief, Surgical Oncology
Principal Investigators
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Alexander Stojadinovic
Role: PRINCIPAL_INVESTIGATOR
Walter Reed Army Medical Center
Locations
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Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Countries
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References
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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.
Other Identifiers
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03-20010
Identifier Type: -
Identifier Source: org_study_id
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