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临床试验/NCT07386912
NCT07386912尚未招募不适用

Investigation of the Effects of Oxidized Antigens on the T-Cell Response and the Epigenetic Reprogramming of Neutrophils in Lung Diseases - OXIGENE -

Research Center Borstel2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
2
主要终点
Characterization of the neutrophil granulocyte epigenome

研究概览

简要总结

The OXIGENE study is a research project that aims to better understand how the immune system behaves in people with lung diseases such as asthma, COPD, pneumonia, tuberculosis, and viral lung infections. By analyzing a single blood sample, the study examines how certain immune cells react during inflammation and infection, and whether lasting changes in these cells influence how strongly the body responds to disease. Although participants do not receive direct medical benefit, the results may help improve future diagnosis and treatment of lung diseases by providing deeper insight into immune responses.

详细描述

The OXIGENE study is an observational research project that explores how the human immune system responds in different lung diseases, including asthma, COPD, pneumonia, tuberculosis, and viral lung infections such as COVID-19 or influenza. The study focuses on two key components of the immune system: neutrophils, which are among the first immune cells to respond to inflammation, and T cells, which play an important role in longer-term immune defense. Researchers investigate whether neutrophils show lasting changes in their behavior during lung disease and how these changes may differ depending on the type of illness or individual patient characteristics. In people with tuberculosis, the study also examines whether chemical changes to bacterial proteins caused by inflammation influence how strongly T cells are activated.

Participation in the study involves a single blood draw, similar to a routine blood test, with no medications, interventions, or follow-up visits required. The study does not provide direct medical benefit to participants, but the risks are minimal and limited to those associated with blood sampling. By improving the understanding of how immune responses are altered in lung diseases, the OXIGENE study aims to generate knowledge that could support the development of better diagnostic tools and more targeted treatments for future patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of an acute or chronic inflammatory lung disease, infectious or non-infectious, including asthma, COPD, pneumonia, tuberculosis, or viral pulmonary infection (e.g., COVID-19, influenza).
  • Age ≥ 18 years at the time of informed consent.
  • Ability to provide informed consent and consent to the collection and processing of clinical and laboratory data, as well as to the analysis of blood samples as part of study participation.
  • Sufficient physical condition to undergo a single venous blood draw (approximately 50 mL), as assessed by the treating physician.

排除标准

  • Active malignant disease or ongoing cancer therapy (e.g., chemotherapy or immunotherapy), due to potential immunological confounding.
  • Immunosuppressive therapy or known severe immunodeficiency that could interfere with the interpretation of cellular immune responses.
  • Pregnancy or breastfeeding, for general research-ethical reasons and to protect vulnerable populations.
  • Acute unstable clinical condition that, in the opinion of the treating physician, makes study participation unreasonable.
  • Known intolerance to blood sampling or relevant hematological disorders that could compromise the safety or feasibility of venipuncture.
  • Lack of capacity to provide informed consent or insufficient understanding of the study content despite supportive explanation.

研究组 & 干预措施

Asthma

Patients with Asthma

干预措施: Characterization of the neutrophil granulocyte epigenome (Other)

COPD

Patients with chronic obstructive pulmonary disease

干预措施: Characterization of the neutrophil granulocyte epigenome (Other)

Viral pneumonia

Patients suffering from viral pneumonia, e.g. COVID-19 or Influenza

干预措施: Characterization of the neutrophil granulocyte epigenome (Other)

Bacterial pneumonia

Patients suffering from bacterial pneumonia

干预措施: Characterization of the neutrophil granulocyte epigenome (Other)

Tuberculosis

Patients treated for tuberculosis

干预措施: Characterization of the neutrophil granulocyte epigenome (Other)

Tuberculosis

Patients treated for tuberculosis

干预措施: Characterization of the T-cell immune response to to various oxidatively modified mycobacterial antigens (Other)

结局指标

主要结局

Characterization of the neutrophil granulocyte epigenome

时间窗: 2030

Stratification of patients with different lung diseases based on epigenetic signatures of neutrophils: Epigenetics: identification of disease-specific differences in DNA methylation patterns and transcriptional profiles (RNA sequencing).

Characterization of functional signatures

时间窗: 2030

Stratification of patients with different lung diseases based on functional signatures of neutrophils: Functional reactivity: quantitative assessment of reactive oxygen species production (oxidative burst) and cellular cell death (e.g., Sytox Green, Annexin V/PI) following stimulation with defined stimuli (e.g., PMA, LPS, Gram-positive/Gram-negative bacteria, BCG, Mycobacterium tuberculosis).

次要结局

  • Influence of demographic and clinical variables(2030)
  • Identification of subgroups within diseases(2030)

研究者

发起方
Research Center Borstel
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jan Heyckendorf

Prof. Dr. med. Jan Heyckendorf

University Hospital Schleswig-Holstein

研究点 (2)

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