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

NCT02269878 | Completed

• 1 other identifier: Master (No14)
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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)

Conditions

Malignant Pleural Mesothelioma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• progression free survival (PFS)

  one year

• overall survival (OS)

  one year

• estimation of treatment related toxicity

  during the chemotherapy period, average duration 4 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with malignant pleural mesothelioma (MPM)

You may qualify if:

• Patients with histologically confirmed Malignant Pleural Mesothelioma
• Age of 18 years or more.
• first-line chemotherapy with platinum-Based agents

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abbasia, Egypt

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: African Union organization St. Abbsia, Cairo, Egypt

Study Record Dates

• First Submitted: October 11, 2014
• First Posted: October 21, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 3, 2018

Record last verified: 2017-12

Locations

EG (1)