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

November 16, 2023 updated by: LI YAN
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

477

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: YI QiaoYan, master
  • Phone Number: +8613256729100
  • Email: sdytyqy@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of myelosuppression (≤150 days)
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Estimated)

November 20, 2023

Study Record Updates

Last Update Posted (Estimated)

November 20, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QFS-LY-2022-GSTP1-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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