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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02269878
Other study ID # Master (No14)
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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