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Report for Clinical Trial NCT02269878

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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)

NCT02269878 Malignant Pleural Mesothelioma
MeSH:Mesothelioma


Primary Outcomes

Description: 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).

Measure: response rate

Time: After 6 cycles of chemotherapy (each cycle is 21 days )

Secondary Outcomes

Description: 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

Measure: progression free survival (PFS)

Time: one year

Description: time is defined as the time from day 1 of chemotherapy to death from any cause.

Measure: overall survival (OS)

Time: one year

Description: 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.

Measure: estimation of treatment related toxicity

Time: during the chemotherapy period, average duration 4 months

Time Perspective: Prospective

Cohort


There is one SNP

SNPs


1 rs1800682

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

- 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) Malignant Pleural Mesothelioma Mesothelioma 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.



HPO Nodes