Lymph Node Counts in Endometrial Cancer Staging

Completed

• Conditions: Endometrial Cancer

• Registration Number: NCT02335775
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2014-12-15
• Study First Submitted QC: 2015-01-07
• Study First Posted: 2015-01-12
• Primary Completion: 2015-03
• Study Completion: 2015-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total gross node identification	0-14 days post op
Percentage of lymph nodes showing metastatic cancer (%NM)	0-14 days post op

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States