跳至主要内容
临床试验/NCT05746598
NCT05746598招募中不适用

Effect of Genetic and Epigenetic Factors on the Clinical Response and Toxicity to Cisplatin Among Egyptian Non-small Cell Lung Cancer Patients

Ain Shams University1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Neven Sarhan

Lecturer

Misr International University

研究点 (1)

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