An observational study in Endometrial Cancer, sponsored by Duke University. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2016-01-21.
Sponsored by Duke University · Observational
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.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 446 are open to participants now.
This study's enrollment of 120 is below the median of 179 across 321 observational studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Woman over the age of 18 diagnosed with grade 3, clear cell, serous or sarcoma types of endometrial cancer
Exclusion Criteria:
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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
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Duke University