Serum Histone Succinylation as a Novel Prognostic Biomarker in Hematological Malignancies

Обзор

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 )

Вмешательства

• Другое 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.

Первичные конечные точки

• To evaluate the differences in serum histone succinylation levels between patients with hematologic malignancies and healthy individuals [Срок оценки: Baseline]
• the correlation between serum histone succinylation modification levels and different types of tumors as well as tumor stages [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Inclusion Criteria tumor group

• ≥ 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

1)≥ 18 years old , regardless of gender; 2)Non-cancer patients undergoing health checkups;

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07131449 · chase018 · chase018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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