跳至主要内容
临床试验/NCT01776385
NCT01776385已完成不适用

Detection and Characterization of Circulating Tumor Cells in Patients With Malignant Pleural Mesothelioma: Towards a New Phase in the Understanding of the Natural History of This Cancer?

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2012年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
2
主要终点
Evaluation of presence / absence of CTC on the global survival

研究概览

简要总结

Malignant pleural mesothelioma (MPM) has a growing incidence and in spite of early diagnostic, their outcome remains dismal. The evolution of MPM is often local with rare distant metastases. There is now a sizable body of evidence that metastases could develop from circulating tumor cells (CTC) spread in blood before or during surgery. Thus, sensitive and specific detection of CTC in blood is considered as a potentially relevant predictive biomarker for patients with carcinomas. In exchange, the prognostic value of CTC in MPM has not yet been evaluated.

Indeed, the main goal for preoperative detection of CTC is to identify patients with high risk of recurrence after surgery, in order to perform more adapted therapeutic strategy. Despite several studies reported about CTC detection, methodological aspects concerning sensitivity, specificity and reproducibility have prevented a clear appraisal of their clinical impact. Thus, the aim of our study is to evaluate the presence and the prognostic value of CTC in MPM by a double approach. In our setting, cytopathological analysis of circulating non hematological cells (CNHC), of epithelial origin, isolated according to their size (ISET, Isolation by Size of Epithelial Tumor cells) along with immunomagnetic selection, identification and enumeration of circulating epithelial cells in peripheral blood (CellSearch method) is considered a promising approach.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Group patients

Experimental

Patients with Malignant Pleural Mesothelioma (all stages)

干预措施: Blood sampling (Other)

Control group

Placebo Comparator

Patients with pneumothorax or of benign tumor of the thyroid

干预措施: Control Group (Other)

结局指标

主要结局

Evaluation of presence / absence of CTC on the global survival

时间窗: from Baseline in Systolic Blood Pressure at 6 months

Value forecasts of the presence / absence of CTC on the global survival estimated by the estimation and the test of meaning at 0 of the immediate relative risk (fate ratio) in a model at proportional risk.

次要结局

  • Value forecasts of the number of CTC on the global survival estimated by the risk(from Baseline in Systolic Blood Pressure at 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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