Molecular Predictors of Pemetrexed and Carboplatin Response in Malignant Pleural Mesothelioma (MPM) Patients
Pharmacogenetics of Pemetrexed and Carboplatin in Malignant Pleural Mesothelioma Patients
1 other identifier
observational
121
1 country
1
Brief Summary
The aim of the present study is to investigate the molecular predictors of pemetrexed and carboplatin response in tumor samples of a series of MPM patients extracting the DNA and genotyping for the TSER polymorphism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2009
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 23, 2009
CompletedFirst Posted
Study publicly available on registry
March 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedDecember 2, 2014
November 1, 2014
2.9 years
March 23, 2009
December 1, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the expression and allelic variants of a panel of candidate genes involved in the resistance to drugs, the genome wide copy number changes in patients treated with drugs combination in the first line
one year
Secondary Outcomes (1)
Evaluate retrospectively the correlation between gene expression and polymorphisms in candidate genes and array-CGH data, immunohistochemistry data, and clinical data.
one year
Eligibility Criteria
Malignant Pleural Mesothelioma patients treated with carboplatin and pemetrexed
You may qualify if:
- MPM diagnosis
- Availability of tumor tissue to perform analysis
You may not qualify if:
- Other primary diagnosis
- No archival tissue available
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Related Publications (1)
Zucali PA, Giovannetti E, Destro A, Mencoboni M, Ceresoli GL, Gianoncelli L, Lorenzi E, De Vincenzo F, Simonelli M, Perrino M, Bruzzone A, Thunnissen E, Tunesi G, Giordano L, Roncalli M, Peters GJ, Santoro A. Thymidylate synthase and excision repair cross-complementing group-1 as predictors of responsiveness in mesothelioma patients treated with pemetrexed/carboplatin. Clin Cancer Res. 2011 Apr 15;17(8):2581-90. doi: 10.1158/1078-0432.CCR-10-2873. Epub 2011 Jan 24.
PMID: 21262916DERIVED
Biospecimen
The paraffin-embedded tumor specimens of patients will be collected. The tumor RNA and DNA will be extracted and genotyping, gene expression and gene copy number analyses will be performed with validated PCR and array-CGH techniques.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Armando Santoro, MD
Istituto Clinico Humanitas
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2009
First Posted
March 24, 2009
Study Start
January 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
December 2, 2014
Record last verified: 2014-11