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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Characterization of the neutrophil granulocyte epigenome
  Characterization of epigenomic differences in neutrophils from patients with different lung diseases (asthma, COPD, pneumonia, tuberculosis, and viral pulmonary infections such as COVID-19 and influenza) by identifying disease-specific epigenetic and functional signatures
• Другое Characterization of the T-cell immune response to to various oxidatively modified mycobacterial antigens
  Investigation of the response (activation/stimulation) of antigen-specific T cells from patients with tuberculosis to various oxidatively modified mycobacterial antigens, with the aim of determining whether changes in the redox status of these antigens measurably influence the adaptive immune response.

Первичные конечные точки

• Characterization of the neutrophil granulocyte epigenome [Срок оценки: 2030]
• Characterization of functional signatures [Срок оценки: 2030]

Вторичные конечные точки (2)

• Influence of demographic and clinical variables [Срок оценки: 2030]
• Identification of subgroups within diseases [Срок оценки: 2030]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Германия · 2 центра

• Medical Service Center MVZ, Research Center Borstel, Leibniz Lung Center — Borstel
• Department of Pulmonology, University Hospital Schleswig-Holstein — Kiel

Идентификаторы

NCT: NCT07386912 · OXIGENE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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