Effect of FAS and FAS Ligand Polymorphisms on Patients With Platinum-Based -Treated Malignant Pleural Mesothelioma

Completed

• Conditions: Malignant Pleural Mesothelioma

• Registration Number: NCT02269878
• Lead Sponsor: Ain Shams University

Brief 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)

Detailed 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).

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-10-11
• Study First Submitted QC: 2014-10-18
• Study First Posted: 2014-10-21
• Primary Completion: 2016-06
• Study Completion: 2016-12
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-30
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
response rate	After 6 cycles of chemotherapy (each cycle is 21 days )	Tumor response will be evaluated after the third (initial evaluation response) and the sixth (confirmation of initial response) chemotherapy cycle according to the modified Response Evaluation Criteria in Solid Tumors. Patients will be assigned to one of following groups: complete response (CR), Partial response (PR), Stable disease (SD) and progressive disease (PD).

Secondary Outcome Measures

Name	Time	Method
progression free survival (PFS)	one year	Progression-free survival (PFS) time is defined as the time from day 1 of chemotherapy to the day of documented disease progression or to death from any cause
overall survival (OS)	one year	time is defined as the time from day 1 of chemotherapy to death from any cause.
estimation of treatment related toxicity	during the chemotherapy period, average duration 4 months	Hematologic (anemia, neutropenia, and thrombocytopenia) and non hematologic (nausea/vomiting, alopecia and nephrotoxicity) toxicities will be evaluated according to the National Cancer Institute-Common Toxicity Criteria. The worst degree of toxicity experienced throughout the treatment is used for the analysis. Toxicities of grade 2 or higher will be considered as clinically relevant.

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Abbasia, Egypt