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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LI YAN

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings