跳至主要内容
临床试验/NCT06140082
NCT06140082尚未招募不适用

Study on the Association of GSTP1 and Other Gene Polymorphisms With Platinum-induced Myelosuppression

LI YAN0 个研究点目标入组 477 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
477
主要终点
Incidence of myelosuppression (≤150 days)

研究概览

简要总结

This study intends to design a retrospective and prospective, cohort study to explore the association between genetic polymorphism of GSTP1 A313G rs1695 or others and adverse effects of platinum drugs, aiming to explore the risk factors of myelosuppression caused by platinum drugs, and provide data support for optimizing anti-tumor chemotherapy regimen, improve medication safety and improve the compliance of chemotherapy in patients.

详细描述

Patients with pulmonary malignant tumors receiving platinum-containing chemotherapy regimen were included in the retrospective and prospective bidirectional cohort study to collect the basic information of the subjects, including gender, age, smoking history, primary site, basic liver and kidney function, chemotherapy regimen, etc. The polymorphisms of glutathione S transferase (GSTP1 A313G) were detected by Sanger dideoxy termination sequencing. To study the risk factors related to myelosuppression during chemotherapy, and to preliminarily explore the characteristics of myelosuppression caused by combination chemotherapy with platinum.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with non-small cell lung cancer with clear imaging or pathological evidence
  • Using a chemotherapy regimen containing platinum
  • Conducted blood routine and biochemical tests
  • Signed informed consent

排除标准

  • Blood routine and other relevant tests were not performed
  • Suffering from primary bone marrow system disease
  • Other reasons for not meeting the experimental requirements

结局指标

主要结局

Incidence of myelosuppression (≤150 days)

时间窗: The platinum-based regimen was followed by 4 to 6 cycles of chemotherapy (each cycle is 28 days), 4 visits per treatment cycle, and day0, day1, day2-5, day6-21 after chemotherapy were recorded

Myelosuppression was judged according to WHO grading criteria

次要结局

未报告次要终点

研究者

发起方
LI YAN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

LI YAN

professor

Qianfoshan Hospital

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