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

Sponsor

LI YAN (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06140082

Collaborator

(none)

477

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Genetic: GSTP1 A313G （AA）

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

477 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Gene mutation-type group According to the characteristics of the patient's own disease, the clinician develops the corresponding medication regimen, and the patient uses one of the target drugs, cisplatin/carboplatin/nedaplatin/loplatin, or other regimen containing the target drug. Peripheral blood of patients was collected, genetic testing was performed, GSTP1 mutant (AG/GG) was classified into this group, and the time and degree of myelosuppression in this group were recorded.
Gene wild-type group According to the characteristics of the patient's own disease, the clinician develops the corresponding medication regimen, and the patient uses one of the target drugs, cisplatin/carboplatin/nedaplatin/loplatin, or other regimen containing the target drug. Peripheral blood of patients was collected for genetic testing, GSTP1 wild type (AA) was classified into this group, and the time and degree of myelosuppression in this group were recorded.	Genetic: GSTP1 A313G （AA） 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. The wild type (AA) and mutant type (AG/GG) were divided into two groups.

Arm

Intervention/Treatment

Gene mutation-type group

According to the characteristics of the patient's own disease, the clinician develops the corresponding medication regimen, and the patient uses one of the target drugs, cisplatin/carboplatin/nedaplatin/loplatin, or other regimen containing the target drug. Peripheral blood of patients was collected, genetic testing was performed, GSTP1 mutant (AG/GG) was classified into this group, and the time and degree of myelosuppression in this group were recorded.

Gene wild-type group

According to the characteristics of the patient's own disease, the clinician develops the corresponding medication regimen, and the patient uses one of the target drugs, cisplatin/carboplatin/nedaplatin/loplatin, or other regimen containing the target drug. Peripheral blood of patients was collected for genetic testing, GSTP1 wild type (AA) was classified into this group, and the time and degree of myelosuppression in this group were recorded.

Genetic: GSTP1 A313G （AA）

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. The wild type (AA) and mutant type (AG/GG) were divided into two groups.

Outcome Measures

Primary Outcome Measures

Incidence of myelosuppression (≤150 days) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

LI YAN

Investigators

Principal Investigator: Peng Jing, doctor, Affiliated hospital of jining medical college
Principal Investigator: Guo Nan, doctor, Shandong Provincial Hospital
Principal Investigator: Guo LuBo, doctor, Jinan Municipal Central Hospital
Principal Investigator: Liu Lun, doctor, Tai 'an City Central Hospital
Principal Investigator: Zhang ZongLin, doctor, Linyi People's Hospital
Principal Investigator: Di HuiFeng, doctor, Jinan Municipal People's Hospital
Principal Investigator: Sun DeQing, doctor, The Second Hospital of Shandong University
Principal Investigator: Zhang XiaoLi, doctor, Shandong Provincial Third Hospital
Principal Investigator: Liu JianFang, doctor, People's Hosital of Rizao
Principal Investigator: si JiGang, doctor, Zibo Central Hospital
Principal Investigator: Chen HaiSheng, doctor, Shandong Provincial Tumor Hospital
Principal Investigator: Bi HengTai, doctor, Weifang Central Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

LI YAN, professor, Qianfoshan Hospital

ClinicalTrials.gov Identifier:

NCT06140082

Other Study ID Numbers:

QFS-LY-2022-GSTP1-001

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Nov 18, 2023