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Lymph Node Counts in Endometrial Cancer Staging

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT02335775
Collaborator
(none)
120
Enrollment
1
Location
86
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purposes of this study are to determine whether total lymph node count or the percentage of identified nodes with metastatic disease are influenced by (1) the method of categorizing tissue specimens or (2) the techniques of pathologic processing following lymphadenectomy.

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Study of the Impact of Surgical and Pathologic Tissue Sampling Methods on Lymph Node Counts and Detection of Lymph Node Metastasis in Endometrial Cancer Staging
    Study Start Date :
    Jul 1, 2008
    Actual Primary Completion Date :
    Mar 1, 2015
    Actual Study Completion Date :
    Sep 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Total gross node identification [0-14 days post op]

    2. Percentage of lymph nodes showing metastatic cancer (%NM) [0-14 days post op]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Uterine cancer with one of the following pathologies: serous, clear cell, sarcoma or grade 3 differentiation

    • surgical candidate

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Medical Center Durham North Carolina United States 27710

    Sponsors and Collaborators

    • Duke University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT02335775
    Other Study ID Numbers:
    • Pro00008993
    First Posted:
    Jan 12, 2015
    Last Update Posted:
    Jan 21, 2016
    Last Verified:
    Jan 1, 2016
    Additional relevant MeSH terms:
    Endometrial Neoplasms

    Study Results

    No Results Posted as of Jan 21, 2016