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Lymph Node Counts in Endometrial Cancer Staging

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02335775
Enrollment
120
Registered
2015-01-12
Start date
2008-07-31
Completion date
2015-09-30
Last updated
2016-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

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.

Interventions

None listed

Sponsors

Duke University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
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

\-

Design outcomes

Primary

MeasureTime frame
Total gross node identification0-14 days post op
Percentage of lymph nodes showing metastatic cancer (%NM)0-14 days post op

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026