Pharmacogenetics Of Vinorelbine In Malignant Pleural Mesothelioma Patients
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|ClinicalTrials.gov Identifier: NCT01865045|
Recruitment Status : Unknown
Verified February 2017 by Armando Santoro, MD, Istituto Clinico Humanitas.
Recruitment status was: Active, not recruiting
First Posted : May 30, 2013
Last Update Posted : February 10, 2017
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
|Condition or disease|
|Malignant Pleural Mesothelioma|
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.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Pharmacogenetics of Vinorelbine in Malignant Pleural Mesothelioma Patient|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
- Expression of TUBB3 and BRCA1 in MPM tumor tissue by immunohistochemistry and RT-PCR. [ Time Frame: 2 months ]
- Association of expression of TUBB3 and BRCA1 with clinical outcome (response, survival) . [ Time Frame: 2 months ]
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865045
|Istituto Clinico Humanitas|
|Rozzano, Milan, Italy, 20089|
|Principal Investigator:||armando santoro, MD||Istituto Clinico Humanitas|