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临床试验/NCT02335775
NCT02335775已完成不适用

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

Duke University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Total gross node identification

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Total gross node identification

时间窗: 0-14 days post op

Percentage of lymph nodes showing metastatic cancer (%NM)

时间窗: 0-14 days post op

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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