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临床试验/NCT01604642
NCT01604642已完成不适用

Role of Activin A (ActA) in the Human Cancer Cachexia

Cliniques universitaires Saint-Luc- Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
Circulating Activin A level

研究概览

简要总结

The goal of the investigators study is to investigate the role of a hormone named Activin A (ActA) in the development of the skeletal muscle atrophy caused by cancer. According to the investigators hypothesis, ActA could be released by the tumor and activate a muscle atrophy gene program. To answer this question, the investigators plan first to compare circulating levels of ActA in cancer patients with and without cachexia. In a second step, the investigators would like to assess whether ActA circulating levels are predictive for the development of cachexia and short survival.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • 18-year-old or older
  • Colorectal or lung cancer demonstrated by histology or cytology
  • New diagnosis or new recurrence
  • Expected survival more than 3 months
  • No previous history of other cancer in the last 5 years
  • No pregnancy or lactation
  • Signed informed consent

排除标准

  • Non-caucasian
  • Major digestive malabsorption
  • Major depression
  • Artificial nutrition
  • Height doses of steroids (>1 mg/kg hydrocortisone equivalent)
  • Hyperthyroidism
  • Other causes of malnutrition
  • Expected survival less than 3 months
  • Severely impaired walking
  • Anticoagulants or antiplatelet therapy
  • Disability or medical condition which might prevent the compliance to the protocol
  • Any conditions which may prevent the compliance to the protocol
  • Performance status ECOG > ou = 4
  • Participation to other clinical studies

研究组 & 干预措施

cachectic versus no cachectic patients

Other

blood tests, muscular biopsies

干预措施: blood tests and muscular biopsies (Other)

结局指标

主要结局

Circulating Activin A level

时间窗: 2 years

次要结局

  • Muscle strength as measured by grip strength(2 years)
  • Quality of life as assessed using the QLQ-C30(2 years)
  • Body composition measured by bioimpedance(2 years)
  • Dietary assessment measured by SNAQ score and 3-Day intake(2 years)
  • Body mass index(2 years)
  • Mid arm muscle circumference calculated by the triceps skinfold and the mid arm circumference(2 years)

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

研究点 (2)

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