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.
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.
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.
The study population includes only adult patients (≥18 years) with lung diseases who are capable of providing informed consent and are medically fit for a single venous blood draw. Minors, healthy volunteers, and adults lacking the capacity to consent are not included, as consent by legal representatives is not provided for, and the study involves no interventions beyond blood sampling. Women of childbearing potential may participate regardless of contraceptive use, as study participation poses no additional risk. Patients with insufficient German language proficiency may also be included; in such cases, study information is provided orally in a language the participant fully understands by a qualified translator, with the translation process documented, and written consent is given using the German-language consent form once full understanding has been ensured, allowing all participants to make an informed and voluntary decision.
Cohort
Prospective
Characterization of the neutrophil granulocyte epigenome
Other interventionCharacterization 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
Characterization of the T-cell immune response to to various oxidatively modified mycobacterial antigens
Other interventionInvestigation 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.
Characterization of the neutrophil granulocyte epigenome
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
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).
Influence of demographic and clinical variables
Correlation of demographic and clinical variables (age, sex, disease severity, medication, comorbidities) with epigenetic and functional parameters
Identification of subgroups within diseases
Exploratory identification of subgroups with characteristic or divergent profiles within the studied patient cohorts
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Research Center Borstel
Lead sponsor
University Hospital Schleswig-Holstein
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
