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临床试验/NCT01105468
NCT01105468终止不适用

Leistungsbewertungsprüfung: Atemluftanalyse für Die Diagnose Von Brustkrebs, für Die Überwachung Der Therapie Und für Die Voraussage Des Metastasenrisikos

Ionimed Analytik GmbH1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
202
试验地点
1
主要终点
Breath gas markers

研究概览

简要总结

The volatile content of the exhaled breath gas of mamma carcinoma patients will be chemically analyzed by proton-transfer-reaction time of flight mass spectrometry.

The goal of the study is to determine typical breath gas components that allow to distinguish patients with mamma carcinoma from women without carcinoma. Further, the investigators will test whether these breath gas markers can be used as tumor markers, which change in a typical manner during the progress of the disease. Finally the data will be investigated for the presence of marker components, that identify patients who will develop metastasis.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Mamma carcinoma diagnosed by histology (cases)
  • Mamma carcinoma excluded by radiology (controls)
  • At the time of diagnosis before surgery
  • At the beginning and during chemotherapy;

排除标准

  • No informed consent form singed

结局指标

主要结局

Breath gas markers

时间窗: 3 years

Breath gas markers that allow to distinguish patients with mamma carcinoma from women without carcinoma;

次要结局

未报告次要终点

研究者

发起方
Ionimed Analytik GmbH
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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