Effect of Genetic and Epigenetic Factors on the Clinical Response and Toxicity to Cisplatin Among Egyptian Non-small Cell Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Nephrotoxicity
研究概览
简要总结
Lung cancer is the leading cause of death worldwide, with non-small-cell lung cancer (NSCLC) being the most common histotype according to the global cancer observatory 2022. A variety of therapeutic options for advanced/metastatic non-oncogene-addicted NSCLC have recently been approved based on their impact on patient outcomes in terms of survival and safety profile. Current guidelines advocate for personalized treatment options based on molecular and immunologic characteristics, which drives the physician's decision toward tailored oncology.
In the last two to three decades, hundreds of cancer biological prognostic markers for non-small cell lung cancer have been proposed. Although they have shown a potential in this field, validation studies are still required and, to date, there is in sufficient evidence to recommend the routine clinical use of any of these putative biomarkers. Therefore, the discovery of robust prognostic and/or predictive biomarkers in patients with non-small cell lung cancer is imperative for advancing treatment strategies for the disease and improving patient care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSCLC cancer patients treated with Cisplatin-containing chemotherapy.
- •Measurable disease.
- •Age of 18 years to 80 years.
排除标准
- •Non-small cell lung cancer patients who had undergone radiotherapy or chemotherapy.
- •Pregnant and lactating females.
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin.
- •Any other medical or psychiatric condition or severe or chronic laboratory abnormality making the inclusion of the patient in the study inappropriate in the opinion of the investigator.
研究组 & 干预措施
1
NSCLC patients Who developed Toxicity to Chemotherapeutic agents
干预措施: Cisplatin injection (Drug)
2
NSCLC patients Who did not developToxicity to Chemotherapeutic agents
干预措施: Cisplatin injection (Drug)
结局指标
主要结局
Nephrotoxicity
时间窗: 6 months
Change in Creatinine Clearance
次要结局
- Serum creatinine(6 month)
- Blood urea nitrogen(6 months)
- Cardiotoxicity(6 months)
研究者
Neven Sarhan
Lecturer
Misr International University
