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

NCT06140082 | Unknown FDA Drug

• 1 other identifier: QFS-LY-2022-GSTP1-001
• Study Type: observational
• Target: 477
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of myelosuppression (≤150 days)

  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

Study Arms (2)

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）

Interventions

GSTP1 A313G （AA） GENETIC

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.

Gene wild-type group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• LI YAN: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Peng Jing, doctor

  Jining Medical University

  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 Province 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

YI QiaoYan, master

CONTACT

+8613256729100; sdytyqy@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: November 18, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-11