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

December 30, 2017 updated by: Ahmed Mohammed Abdo Mohammed Salem, Ain Shams University

The Effect of FAS and FAS Ligand Genetic Polymorphisms on the Clinical Outcome of Patients With Malignant Pleural Mesothelioma Treated With Platinum-Based Regimens

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)

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbasia
      • Cairo, Abbasia, Egypt
        • Ain shams university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with malignant pleural mesothelioma (MPM)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
people with MPM with Thymine/Thymine,Thymine/cytosine genotype
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.
people with MPM, Cytosine/Cytosine genotype
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response rate
Time Frame: 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).
After 6 cycles of chemotherapy (each cycle is 21 days )

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival (PFS)
Time Frame: 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
one year
overall survival (OS)
Time Frame: one year
time is defined as the time from day 1 of chemotherapy to death from any cause.
one year
estimation of treatment related toxicity
Time Frame: 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.
during the chemotherapy period, average duration 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 11, 2014

First Submitted That Met QC Criteria

October 18, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Actual)

January 3, 2018

Last Update Submitted That Met QC Criteria

December 30, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Master (No14)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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