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Not yet recruitingNCT07131449succinylationUpdated Aug 20, 2025

Serum Histone Succinylation as a Novel Prognostic Biomarker in Hematological Malignancies

An observational study in Leukemia and Lymphoma, sponsored by The First Affiliated Hospital of Xinxiang Medical College. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-20.

Sponsored by The First Affiliated Hospital of Xinxiang Medical College · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
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Study 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 )

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Conditions studied

  • Leukemia
  • Lymphoma

Keywords

  • leukemia
  • lymphoma
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In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 200 is above the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

The First Affiliated Hospital of Xinxiang Medical College is the lead sponsor of 41 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • 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.

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What researchers measure

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

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Study locations

No study locations are listed for this record.

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References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 12, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07131449
Lead sponsor
The First Affiliated Hospital of Xinxiang Medical College
Responsible party
Sponsor
First posted
Aug 20, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Aug 20, 2025

Study contacts

guoqing LYU, Dr.
Contact
gqlv6@qq.com
+8618567557353
guoqing LYU, Dr.
principal investigator · The First Affiliated Hospital of Xinxiang Medical College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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