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Serum Histone Succinylation as a Novel Prognostic Biomarker in Hematological Malignancies

Serum Histone Succinylation as a Novel Prognostic Biomarker in Hematological Malignancies

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07131449
Acronym
succinylation
Enrollment
200
Registered
2025-08-20
Start date
2025-09-01
Completion date
2027-12-31
Last updated
2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphoma

Keywords

leukemia, lymphoma

Brief 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 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 )

Interventions

OTHERThis 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.

Sponsors

The First Affiliated Hospital of Xinxiang Medical College
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

tumor group 1. ≥ 18 years old , regardless of gender; 2. 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;

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

Design outcomes

Primary

MeasureTime frameDescription
To evaluate the differences in serum histone succinylation levels between patients with hematologic malignancies and healthy individualsBaselineTo 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 stagesthrough study completion, an average of 1 yearTo 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.

Contacts

Primary Contactguoqing LYU, Dr.
gqlv6@qq.com+8618567557353

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026