The Effect of FAS and FAS Ligand Genetic Polymorphisms on the Clinical Outcome of Patients With Malignant Pleural Mesothelioma Treated With Platinum-Based Regimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
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)
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed Malignant Pleural Mesothelioma
- •Age of 18 years or more.
- •first-line chemotherapy with platinum-Based agents
排除标准
- •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)
结局指标
主要结局
response rate
时间窗: 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).
次要结局
- progression free survival (PFS)(one year)
- overall survival (OS)(one year)
- estimation of treatment related toxicity(during the chemotherapy period, average duration 4 months)
研究者
Ahmed Mohammed Abdo Mohammed Salem
African Union organization St. Abbsia, Cairo, Egypt
Ain Shams University