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

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ClinicalTrials.gov Identifier: NCT02269878
Recruitment Status : Completed
First Posted : October 21, 2014
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohammed Abdo Mohammed Salem, 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)

Condition or disease
Malignant Pleural Mesothelioma

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).

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Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : April 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. overall survival (OS) [ Time Frame: one year ]
    time is defined as the time from day 1 of chemotherapy to death from any cause.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with malignant pleural mesothelioma (MPM)
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269878


Locations
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Egypt
Ain Shams University Hospitals
Cairo, Abbasia, Egypt
Sponsors and Collaborators
Ain Shams University
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Responsible Party: Ahmed Mohammed Abdo Mohammed Salem, African Union organization St. Abbsia, Cairo, Egypt, Ain Shams University
ClinicalTrials.gov Identifier: NCT02269878    
Other Study ID Numbers: Master (No14)
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial