Serum Histone Succinylation as a Novel Prognostic Biomarker in Hematological Malignancies

NCT07131449 | Not Yet Recruiting

• 1 other identifier: chase018
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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. 1.≥ 18 years old , regardless of gender;
2. 2.Non-cancer patients undergoing health checkups;
3. 3.Pregnant women
4. 4.Those with severe mental disorders or language communication barriers
5. 5.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.

Conditions

Leukemia; Lymphoma

Keywords

leukemia; lymphoma

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  through study completion, an average of 1 year

Study Arms (1)

Patient Cohort: 200 patients diagnosed with hematological malignancies

Control Cohort: 200 healthy volunteers

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. OTHER

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

Patient Cohort: 200 patients diagnosed with hematological malignancies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• ≥ 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
• )≥ 18 years old , regardless of gender; 2)Non-cancer patients undergoing health checkups;

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Leukemia; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• guoqing LYU, Dr.

  The First Affiliated Hospital of Xinxiang Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

guoqing LYU, Dr.

CONTACT

+8618567557353; gqlv6@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 20, 2025

Record last verified: 2025-07