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

Malignant Pleural Mesothelioma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02269878
• Other study ID #: Master (No14)
• Status: Completed
• Phase: N/A
• First received: October 11, 2014
• Last updated: December 30, 2017
• Start date: April 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Malignant Pleural Mesothelioma
• Mesothelioma

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate	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	progression free survival (PFS)	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
Secondary	overall survival (OS)	time is defined as the time from day 1 of chemotherapy to death from any cause.	one year
Secondary	estimation of treatment related toxicity	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