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
120 participants
OBSERVATIONAL
2008-07-31
2015-09-30
Brief Summary
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Patients with newly diagnosed endometrial carcinoma of high risk histologic type or uterine carcinosarcoma whose risk of LN metastasis exceeds 15% will be enrolled on this study. Patients will undergo staging to include hysterectomy and selective lymphadenectomy as per the clinical judgment of the primary Gynecologic Oncologist. Type of hysterectomy and the extent and distribution of lymphadenectomy is at the discretion of the surgeon. All patients will be scheduled for surgical staging. Each subject will have lymph nodes harvested on one side divided into specific basins, and on the contralateral side classified only as "pelvic" or "aortic". Surgical node specimens in the operating room will be labeled by (1) specific nodal basins on the randomly determined side as "external iliac", "obturator", "common iliac", "aortic", or "high aortic" and by (2) "pelvic" versus "aortic" (common iliac nodes will be considered as part of the "pelvic" specimen) on the contralateral side.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* surgical candidate
Exclusion Criteria
FEMALE
No
Sponsors
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Duke University
OTHER
Responsible Party
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Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00008993
Identifier Type: -
Identifier Source: org_study_id
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