Clinical trial NCT06140082: Study on the Association of GSTP1 and Other Gene Polymorphisms With Platinum-induced Myelosuppression
Official title: Study on the Association of GSTP1 and Other Gene Polymorphisms With Platinum-induced Myelosuppression
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 477
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-small cell lung cancer with clear imaging or pathological evidence are treated with a platinum-containing chemotherapy regimen

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence of myelosuppression (≤150 days)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Jining Medical University
name: Peng Jing, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Provincial Hospital
name: Guo Nan, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinan Municipal Central Hospital
name: Guo LuBo, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Tai 'an City Central Hospital
name: Liu Lun, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Linyi People's Hospital
name: Zhang ZongLin, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinan Municipal People's Hospital
name: Di HuiFeng, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Hospital of Shandong University
name: Sun DeQing, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Province Third hospital
name: Zhang XiaoLi, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: People's Hosital of Rizao
name: Liu JianFang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Zibo Central Hospital
name: si JiGang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Provincial Tumor Hospital
name: Chen HaiSheng, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Weifang Central Hospital
name: Bi HengTai, doctor
role: PRINCIPAL_INVESTIGATOR
References: