Overview

This trial is active, not recruiting.

Condition malignant pleural mesothelioma
Sponsor Ain Shams University
Start date April 2014
End date June 2016
Trial size 60 participants
Trial identifier NCT02269878, Master (No14)

Summary

To Study the Effect of Polymorphisms in Fas Ligand Gene Promoter Region (rs 763110) and Fas gene (rs1800682) on Platinum-Based regimens used in treatment of malignant pleural mesothelioma (MPM)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
according to Single nucleotide polymorphism analysis of rs 763110, people have one of the following genotypes, Thymine/Thymine,Thymine/Cytosine,Cytosine/Cytosine. we will assign Thymine/Thymine, Thymine/Cytosine to group one and Cytosine/Cytosine to group two. for rs 1800682 people will have one of the following genotypes Adenine/Adenine, Adenine/Guanine or Guanine/Guanine.
according to Single nucleotide polymorphism analysis of rs 763110, people have one of the following genotypes, Thymine/Thymine,Thymine/Cytosine,Cytosine/Cytosine. we will assign Thymine/Thymine, Thymine/Cytosine to group one and Cytosine/Cytosine to group two. for rs 1800682 people will have one of the following genotypes Adenine/Adenine, Adenine/Guanine or Guanine/Guanine.

Primary Outcomes

Measure
response rate
time frame: After 6 cycles of chemotherapy (each cycle is 21 days )

Secondary Outcomes

Measure
progression free survival (PFS)
time frame: one year
overall survival (OS)
time frame: one year
estimation of treatment related toxicity
time frame: during the chemotherapy period, average duration 4 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients with histologically confirmed Malignant Pleural Mesothelioma - Age of 18 years or more. - first-line chemotherapy with platinum-Based agents Exclusion Criteria: - history of prior malignancy. - pregnancy or lactation or any other reason preventing him from taking platinum-Based chemotherapy (AST more than 2.5* Upper Limit of Normal or Serum bilirubin more than 1.5* Upper Limit of Normal)

Additional Information

Official title The Effect of FAS and FAS Ligand Genetic Polymorphisms on the Clinical Outcome of Patients With Malignant Pleural Mesothelioma Treated With Platinum-Based Regimens
Principal investigator Ahmed Mohammed Abdo Mohammed Salem, B.pharm
Description This study tries to find a correlation between single nucleotide polymorphisms (SNP) found in promoter region of Fas Ligand gene (rs 763110) and Fas (rs1800682) and clinical outcome on patients with MPM treated with platinum-Based agents as first line. the patients will have one of three following genotypes : Thymine/Thymine, Thymine/Cytosine or Cytosine/Cytosine (for Fas ligand polymorphism) and Adenine/Adenine, Adenine/Guanine or Guanine/Guanine ( for Fas polymorphism).
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Ain Shams University.