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临床试验/NCT01865045
NCT01865045已完成不适用

Pharmacogenetics of Vinorelbine in Malignant Pleural Mesothelioma Patient

Armando Santoro, MD1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2012年11月最近更新:
适应症

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
1
主要终点
Expression of TUBB3 and BRCA1 in MPM tumor tissue by immunohistochemistry and RT-PCR.

研究概览

简要总结

This is a multicenter retrospective analysis .The aim of the present study is to investigate the molecular predictors of vinorelbine response in tumor samples of a series of MPM patients and evaluate the possible impact on clinical outcome.

Sample size: around 150 patients based on the availability of tumor size

详细描述

Vinorelbine has recently become an alternative option for palliation in selected pemetrexed-pretreated patients with malignant pleural mesothelioma (MPM). However, nowadays there are no definitive data about vinorelbine predictors of response in MPM patients. The identification of molecular predictors of effective therapy is important for maximizing therapeutic efficacy and minimizing useless treatment in cancer patients.

In oncology a pharmacogenetic approach to customize the chemotherapy treatment according to individual as well as tumour genetic characteristics represents a modern and intriguing challenge. Recent studies have suggested that the expression levels of class III β-tubulin (TUBB3) or BRCA1, are related to a survival benefit from vinorelbine chemotherapy among patients with advanced solid malignancies, especially non-small cell lung cancer. There are no data about the predictive factors to vinorelbine in MPM patients. The identification of molecular predictors of effective therapy may allow in the future the development of better therapies.

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •MPM patients treated with vinorelbine in the ≥ second line setting will be retrospectively analyzed
  • •Patients will be selected based on the availability of tumor tissue

排除标准

  • 未提供

结局指标

主要结局

Expression of TUBB3 and BRCA1 in MPM tumor tissue by immunohistochemistry and RT-PCR.

时间窗: 2 months

次要结局

  • Association of expression of TUBB3 and BRCA1 with clinical outcome (response, survival) .(2 months)

研究者

发起方
Armando Santoro, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Armando Santoro, MD

Principal Investigator

Istituto Clinico Humanitas

研究点 (1)

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