Serum Histone Succinylation as a Novel Prognostic Biomarker in Hematological Malignancies

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Xinxiang Medical College

About this trial

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 )

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥ 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

Disqualifiers

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 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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patient Cohort: 200 patients diagnosed with hematological malignancies1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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