Serum Histone Succinylation as a Novel Prognostic Biomarker in Hematological Malignancies

Sponsor
The First Affiliated Hospital of Xinxiang Medical College
Study ID
NCT07131449
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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 Details

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 immunotherapy ) ; control group 1. ≥ 18 years old , regardless of gender; 2. Non-cancer patients undergoing health checkups; 4.2 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 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 )

Key Dates

First listed
Aug 20, 2025
Start date
Sep 1, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Patient Cohort: 200 patients diagnosed with hematological malignancies
    Control Cohort: 200 healthy volunteers

Primary Outcome Measure

To evaluate the differences in serum histone succinylation levels between patients with hematologic malignancies and healthy individuals [ Time Frame: Baseline ]

Central Contacts

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