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Lymph Node Counts in Endometrial Cancer Staging

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ClinicalTrials.gov Identifier: NCT02335775
Recruitment Status : Completed
First Posted : January 12, 2015
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
Duke University

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
Endometrial Cancer

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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 : July 2008
Actual Primary Completion Date : March 2015
Actual Study Completion Date : September 2015



Primary Outcome Measures :
  1. Total gross node identification [ Time Frame: 0-14 days post op ]
  2. Percentage of lymph nodes showing metastatic cancer (%NM) [ Time Frame: 0-14 days post op ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Woman over the age of 18 diagnosed with grade 3, clear cell, serous or sarcoma types of endometrial cancer
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335775


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02335775     History of Changes
Other Study ID Numbers: Pro00008993
First Posted: January 12, 2015    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female