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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06140082
• Other study ID #: QFS-LY-2022-GSTP1-001
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: November 2023
• Source: Qianfoshan Hospital
• Contact: YI QiaoYan, master
• Phone: +8613256729100
• Email: sdytyqy[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 477
• Est. completion date: December 30, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LI YAN

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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