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
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|
|Study Type :||Observational|
|Actual Enrollment :||120 participants|
|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|
- Total gross node identification [ Time Frame: 0-14 days post op ]
- Percentage of lymph nodes showing metastatic cancer (%NM) [ Time Frame: 0-14 days post op ]
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
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|