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临床试验/NCT01349517
NCT01349517Unknown2 期

Health-related Quality of Life of Patients With Esophageal Cancer After Surgery in China: A Prospective Cohort Study From Multi-center

Fudan University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
2 期
入组人数
400
试验地点
1
主要终点
Health related quality of life

研究概览

简要总结

The purpose of this multi-center prospective cohort study is to study the health-related quality of life (HRQL) together with other outcomes of patients with esophageal cancer after surgery in China.

详细描述

  • To study the influence of health-related quality of life of patients with esophageal cancer before and after surgery.
  • To compare the impact of different procedures on the the health-related quality of life of patients with esophageal cancer.
  • To compare morbidities and oncological results(3,5- year survival) from different procedures.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical stage I/II esophageal cancer
  • Normal blood test of basic metabolism panel
  • Pulmonary function: FEV1 > 1.2L, FEV1% > 50%, DLCO > 50%
  • Heart function: NY grade I and grade II

排除标准

  • Mental disorders
  • Combination with other cancers
  • With a previous history of thoracic or ventral surgery

结局指标

主要结局

Health related quality of life

时间窗: postoperative 2 year

Health related quality of life from the different precedure groups (assessed by EORTC QLQ C-30 and OES-18)

次要结局

  • Morbidity Mortality Survival rate(5 years)

研究者

申办方类型
Other

研究点 (1)

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