LeukemiasuccinylationNCT07131449
Serum Histone Succinylation as a Novel Prognostic Biomarker in Hematological Malignancies
An observational study of Leukemia and Lymphoma, run by The First Affiliated Hospital of Xinxiang Medical College.
Trial summary
4. Study Population 4.1 Inclusion Criteria Case group 1)≥ 18 years old , regardless of gender; 2)Hematological malignancies confirmed by cytology, histology , or molecular biology , who require subsequent anti-tumor treatment ( chemotherapy , hematopoietic stem cell transplantation, radiotherapy, or cellular… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- This is observational studies, participants are not assigned an intervention as part of the study.
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Case group 1. ≥ 18 years old , regardless of gender; 2. Hematological malignancies confirmed by cytology, histology , or molecular biology , who require subsequent anti-tumor treatment ( chemotherapy , hematopoietic stem cell transplantation, radiotherapy, or cellular immunotherapy ) ; control group 1)≥ 18 years old , regardless of gender; 2)Non-cancer patients undergoing health checkups; Exclusion criteria 1. Pregnant women 2. Those with severe mental disorders or language communication barriers 3. Other circumstances that the researcher judges to be unsuitable for participation in this study The control group was the same as the case group
Who may be able to join
- ≥ 18 years old , regardless of gender;
- Hematological malignancies confirmed by cytology, histology , or molecular biology (such as leukemia, lymphoma, multiple myeloma, etc.), who require subsequent anti-tumor treatment ( chemotherapy , hematopoietic stem cell transplantation, radiotherapy, or cellular immunotherapy ) ; control group
- 1)≥ 18 years old , regardless of gender; 2)Non-cancer patients undergoing health checkups;
Who cannot join
- Pregnant women
- Those with severe mental disorders or language communication barriers
- Other circumstances that the researcher judges to be unsuitable for participation in this study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
- Study Population 4.1 Inclusion Criteria Case group
1)≥ 18 years old , regardless of gender; 2)Hematological malignancies confirmed by cytology, histology , or molecular biology , who require subsequent anti-tumor treatment ( chemotherapy , hematopoietic stem cell transplantation, radiotherapy, or cellular immunotherapy ) ; control group
Read more
- ≥ 18 years old , regardless of gender;
- Non-cancer patients undergoing health checkups;
4.2 Exclusion criteria
- Pregnant women
- Those with severe mental disorders or language communication barriers
- Other circumstances that the researcher judges to be unsuitable for participation in this study The control group was the same as the case group V. Research Design 5.1 Overall Design This study was a single-center prospective case-control study. 5.2 Research Design Process 5.2.1 Study the specific implementation process 1. Phase 1: Screening population for enrollment i. Conduct ethical review and clinical research plan review for the project; ii. 200 patients with hematological malignancies will be selected , basic information collected , and informed consent signed ; iii: 200 healthy subjects are planned to be selected and basic information collected; 2. Second stage: Collect blood samples and perform serum histone succinylation test Blood samples were collected from all 200 eligible participants and 200 healthy subjects for serum histone succinylation testing ; 3. The third stage: statistical analysis of screening results i. Evaluate the differences in serum histone succinylation between patients with hematological malignancies and healthy controls to validate its value in early screening. ii. Statistical analysis of the correlation between serum histone succinylation and tumor efficacy (including chemotherapy , hematopoietic stem cell transplantation, cellular immunotherapy ) and clinical outcomes . ( Efficacy evaluation was performed using RECIST 1.1 criteria )
- Being tested
- This is observational studies, participants are not assigned an intervention as part of the study.
- Keywords
- leukemia, lymphoma
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is observational studies, participants are not assigned an intervention as part of the study.Other
This is observational studies, participants are not assigned an intervention as part of the study.
| Study group | Role | What they receive |
|---|---|---|
| Patient Cohort: 200 patients diagnosed with hematological malignancies | Control Cohort: 200 healthy volunteers Receives: Other: This is observational studies, participants are not assigned an intervention as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the differences in serum histone succinylation levels between patients with hematologic malignancies and healthy individuals
To evaluate the differences in serum histone succinylation levels between patients with hematologic malignancies and healthy individuals, and to confirm whether there is a significant difference in serum histone succinylation levels between these two groups.
Measured: Baseline
the correlation between serum histone succinylation modification levels and different types of tumors as well as tumor stages
To determine the correlation between serum histone succinylation modification levels and different types of tumors as well as tumor stages, and to statistically analyze the relationship between serum histone succinylation and therapeutic outcomes (including chemotherapy, hematopoietic stem cell transplantation, and cellular immunotherapy) as well as clinical pathological features.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- guoqing LYU, Dr., Principal investigator, The First Affiliated Hospital of Xinxiang Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131449
- Sponsor's protocol ID
- chase018
- Other IDs
- chase018
- Acronym
- succinylation
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Histone Succinylation as a Novel Prognostic Biomarker in Hematological Malignancies
- ClinicalTrials.gov ID
- NCT07131449
- Acronym / sponsor ID
- succinylation / chase018
- Keywords
- leukemia, lymphoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Aug 2025 (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.
- Study Population 4.1 Inclusion Criteria Case group
1)≥ 18 years old , regardless of gender; 2)Hematological malignancies confirmed by cytology, histology , or molecular biology , who require subsequent anti-tumor treatment ( chemotherapy , hematopoietic stem cell transplantation, radiotherapy, or cellular immunotherapy ) ; control group
- ≥ 18 years old , regardless of gender;
- Non-cancer patients undergoing health checkups;
4.2 Exclusion criteria
- Pregnant women
- Those with severe mental disorders or language communication barriers
- Other circumstances that the researcher judges to be unsuitable for participation in this study The control group was the same as the case group V. Research Design 5.1 Overall Design This study was a single-center prospective case-control study. 5.2 Research Design Process 5.2.1 Study the specific implementation process 1. Phase 1: Screening population for enrollment i. Conduct ethical review and clinical research plan review for the project; ii. 200 patients with hematological malignancies will be selected , basic information collected , and informed consent signed ; iii: 200 healthy subjects are planned to be selected and basic information collected; 2. Second stage: Collect blood samples and perform serum histone succinylation test Blood samples were collected from all 200 eligible participants and 200 healthy subjects for serum histone succinylation testing ; 3. The third stage: statistical analysis of screening results i. Evaluate the differences in serum histone succinylation between patients with hematological malignancies and healthy controls to validate its value in early screening. ii. Statistical analysis of the correlation between serum histone succinylation and tumor efficacy (including chemotherapy , hematopoietic stem cell transplantation, cellular immunotherapy ) and clinical outcomes . ( Efficacy evaluation was performed using RECIST 1.1 criteria )
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Cohort: 200 patients diagnosed with hematological malignancies | – | Other: This is observational studies, participants are not assigned an intervention as part of the study.Control Cohort: 200 healthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Case group 1. ≥ 18 years old , regardless of gender; 2. Hematological malignancies confirmed by cytology, histology , or molecular biology , who require subsequent anti-tumor treatment ( chemotherapy , hematopoietic stem cell transplantation, radiotherapy, or cellular immunotherapy ) ; control group 1)≥ 18 years old , regardless of gender; 2)Non-cancer patients undergoing health checkups; Exclusion criteria 1. Pregnant women 2. Those with severe mental disorders or language communication barriers 3. Other circumstances that the researcher judges to be unsuitable for participation in this study The control group was the same as the case group
Key inclusion criteria (3 listed)
- ≥ 18 years old , regardless of gender;
- Hematological malignancies confirmed by cytology, histology , or molecular biology (such as leukemia, lymphoma, multiple myeloma, etc.), who require subsequent anti-tumor treatment ( chemotherapy , hematopoietic stem cell transplantation, radiotherapy, or cellular immunotherapy ) ; control group
- 1)≥ 18 years old , regardless of gender; 2)Non-cancer patients undergoing health checkups;
Key exclusion criteria (3 listed)
- Pregnant women
- Those with severe mental disorders or language communication barriers
- Other circumstances that the researcher judges to be unsuitable for participation in this study
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 |
|---|---|---|
| This is observational studies, participants are not assigned an intervention as part of the study.This is observational studies, participants are not assigned an intervention as part of the study. | Other | Patient Cohort: 200 patients diagnosed with hematological malignancies |
Primary outcome
To evaluate the differences in serum histone succinylation levels between patients with hematologic malignancies and healthy individuals
Time frame: Baseline
To evaluate the differences in serum histone succinylation levels between patients with hematologic malignancies and healthy individuals, and to confirm whether there is a significant difference in serum histone succinylation levels between these two groups.
the correlation between serum histone succinylation modification levels and different types of tumors as well as tumor stages
Time frame: through study completion, an average of 1 year
To determine the correlation between serum histone succinylation modification levels and different types of tumors as well as tumor stages, and to statistically analyze the relationship between serum histone succinylation and therapeutic outcomes (including chemotherapy, hematopoietic stem cell transplantation, and cellular immunotherapy) as well as clinical pathological features.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
guoqing LYU, Dr. principal investigator
The First Affiliated Hospital of Xinxiang Medical College
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Lymphoma, run by The First Affiliated Hospital of Xinxiang Medical College.
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 3 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: opening soon, as of the sponsor's last update on 20 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact guoqing LYU, Dr. (+8618567557353, gqlv6@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the differences in serum histone succinylation levels between patients with hematologic malignancies and healthy individuals (time frame: Baseline). The study lists 2 primary outcomes in all. 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 20 Aug 2025.