Pharmacogenetic Study of Sorafenib In Egyptian Patients With Hepatocellular Carcinoma.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ATG10 genotyping
研究概览
简要总结
This study aims to determine the predictive effect of ATG10 and IL6 genetic polymorphisms in safety and efficacy of sorafenib used for the treatment of Egyptian HCC patients. Moreover, this study will determine the association between genetic polymorphisms of ATG10 and IL6 with HCC severity.
详细描述
A prospective pharmcogentic study for Egyptian HCC patients treating with oral sorafenib.
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
- 100 patients diagnosed with HCC for whom Sorafenib therapy is prescribed (400 mg twice daily) or (200mg twice daily),. will be recruited from Mansoura University Hospital, Mansoura, Egypt.
- At baseline and follow up visits after Sorafenib, all patients will be assessed for complete blood count (CBC), kidney function, liver function, liver enzymes, alpha fetoprotein (AFP) and viral markers. Moreover, triphasic pelviabdominal CT will be performed .
- Blood samples will be collected for ATG10 AND IL6 genotyping.
- Genetic polymorphisms of ATG10 AND IL6 will be detected by real time polymerase chain reaction (RT-PCR).
- Five mls of whole blood will be collected
- Extraction of genomic DNA from blood samples by DNA extraction kit.
- DNA qualification will be performed by Nano drop.
- Genotyping will be done by allelic discrimination using Taqman assays specific for each polymorphism.
- Assays will be done according to manufacturer protocol using real time PCR machine.
- Appropriate statistical tests will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given. Ethical Issue
- Informed consent will be signed by all eligible patients before enrolling in the study.
- All patients' data will be confidential.
Efficacy and Safety outcomes:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosed HCC patient.
- •Child-pugh class A.
- •Performance status 1-2 (ECOG scale)
- •Laboratory investigation : Hemoglobin ≥8.5 mg\dl, INR ≤2.3 ,Albumin≥2.8g\dl, ALT and AST ≤ 3 times the ULN
- •Age ≥20 years.
排除标准
- •Patients refused to sign the written consent.
- •Age > 75 years.
- •Renal failure requiring hemo- or peritoneal dialysis
- •History of cardiac disease
- •Active clinically serious infections
- •Known history of human immunodeficiency virus (HIV) infection
- •Pregnant female
- •Child-pugh class B and C.
- •Performance status 3 or
- •Patient who are indicated for surgical resection or liver transplant (MDT).
研究组 & 干预措施
Sorafenib group
100 patients diagnosed with HCC for whom Sorafenib therapy is prescribed (400 mg twice daily) or (200mg twice daily), will be recruited from Mansoura University Hospital, Mansoura, Egypt.
干预措施: Sorafenib Tablets (Drug)
结局指标
主要结局
ATG10 genotyping
时间窗: 6 months
Gene polymorphism
IL6 genotyping
时间窗: 6 months
Gene polymorphism
Safety Outcomes
时间窗: 6 months
Incidence of side effects such as (diarrhea, anorexia, nausea, vomiting
次要结局
未报告次要终点
研究者
Rehab Werida
Associate Professor
Damanhour University