Serum Histone Succinylation as a Novel Prognostic Biomarker in Hematological Malignancies

NCT ID: NCT07131449

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-12-31

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 )

Conditions

Leukemia; Lymphoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient Cohort: 200 patients diagnosed with hematological malignancies

Control Cohort: 200 healthy volunteers

This is observational studies, participants are not assigned an intervention as part of the study.

Intervention Type: OTHER

This is observational studies, participants are not assigned an intervention as part of the study.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The First Affiliated Hospital of Xinxiang Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

guoqing LYU, Dr.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Xinxiang Medical College

Central Contacts

guoqing LYU, Dr.

Role: CONTACT

gqlv6@qq.com

+8618567557353

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

chase018

Identifier Type: OTHER

Identifier Source: secondary_id

chase018

Identifier Type: -

Identifier Source: org_study_id