Lymph Node Counts in Endometrial Cancer Staging

Endometrial Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

• NCT number: NCT02335775
• Study type: Observational
• Source: Duke University
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Completion date: September 2015