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临床试验/NCT01538498
NCT01538498已完成不适用

A Clinical Trial to Develop a Peritoneal Carcinomatosis Index (PCI) in Ovarian

National Cancer Center, Korea1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2008年4月最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
134
试验地点
1
主要终点
Devleopment for the peritoneal carcinomatosis index (PCI)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

  • Primary objectives: To develop peritoneal carcinomatosis index (PCI) for ovarian cancer, tubal cancer and primary peritoneal cancer that can represent perioperative intraperitoneal tumor burden objectively
  • Secondary objectives: To establish the relationship and find out clinical significance between PCI, tumor location and tumor characteristics

详细描述

Patients with primary ovarian cancer

  • Informed consent
  • Digital photography & Checking PCI (tumor size, number, and Characteristics)
  • Postoperative surveillance(tumor marker, image and physical examination)
  1. Developing the best fitting PCI model to reflect recurrence-free survival and overall survival
  • Selection of items
  • Weighting by items and tumor characteristics
  1. Analysis of prognostic impact of PCI compared to conventional staging system (FIGO stage) for ovarian cancer

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者
否

入选标准

  • •Preoperative clinical diagnosis of ovarian cancer, tubal cancer, and primary peritoneal carcinoma (all stage)
  • •Available preoperative image study (CT and/or MRI and/or PET)
  • •Patients who gave a written informed consent
  • •Patients must be surgical candidate considering medical and psychological condition

排除标准

  • •Patients who refuse to participate or want to withdraw at anytime.

结局指标

主要结局

Devleopment for the peritoneal carcinomatosis index (PCI)

时间窗: 55 months

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sang-Yoon Park

Chief, Center for Uterine Cancer

National Cancer Center, Korea

研究点 (1)

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Development for the Peritoneal Carcinomatosis Index... | 临床试验