Non-small Cell Lung CancerNCT06140082
Study on the Association of GSTP1 and Other Gene Polymorphisms With Platinum-induced Myelosuppression
An observational study of Non-small Cell Lung Cancer, run by LI YAN.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- GSTP1 A313G （AA）
- How many people
- 477 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with non-small cell lung cancer with clear imaging or pathological evidence are treated with a platinum-containing chemotherapy regimen
Who may be able to join
- 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
Who cannot join
- Blood routine and other relevant tests were not performed
- Suffering from primary bone marrow system disease
- Other reasons for not meeting the experimental requirements
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- GSTP1 A313G （AA）
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: GSTP1 A313G （AA） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of myelosuppression (≤150 days)
Myelosuppression was judged according to WHO grading criteria
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 477 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LI YAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, LI YAN, Qianfoshan Hospital
- Investigators
- Peng Jing, doctor, Principal investigator, Affiliated Hospital of Jining Medical UniversityGuo Nan, doctor, Principal investigator, Shandong Provincial HospitalGuo LuBo, doctor, Principal investigator, Jinan Municipal Central HospitalLiu Lun, doctor, Principal investigator, Tai 'an City Central HospitalZhang ZongLin, doctor, Principal investigator, Linyi People's HospitalDi HuiFeng, doctor, Principal investigator, Jinan Municipal People's HospitalSun DeQing, doctor, Principal investigator, The Second Hospital of Shandong UniversityZhang XiaoLi, doctor, Principal investigator, Shandong Province Third hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140082
- Sponsor's protocol ID
- QFS-LY-2022-GSTP1-001
- Status last verified
- Nov 2023
- First submitted
- 4 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Association of GSTP1 and Other Gene Polymorphisms With Platinum-induced Myelosuppression
- ClinicalTrials.gov ID
- NCT06140082
- Acronym / sponsor ID
- QFS-LY-2022-GSTP1-001
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 477 participants (estimated)
- Lead sponsor
- LI YANUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Genetic: GSTP1 A313G （AA）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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with non-small cell lung cancer with clear imaging or pathological evidence are treated with a platinum-containing chemotherapy regimen
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Blood routine and other relevant tests were not performed
- Suffering from primary bone marrow system disease
- Other reasons for not meeting the experimental requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Genetic | Gene wild-type group |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peng Jing, doctor principal investigator
Affiliated Hospital of Jining Medical University
Guo Nan, doctor principal investigator
Shandong Provincial Hospital
Guo LuBo, doctor principal investigator
Jinan Municipal Central Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by LI YAN.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YI QiaoYan, master (+8613256729100, sdytyqy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.