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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthma | Patients with Asthma |
| |
| COPD | Patients with chronic obstructive pulmonary disease |
| |
| Viral pneumonia | Patients suffering from viral pneumonia, e.g. COVID-19 or Influenza |
| |
| Bacterial pneumonia | Patients suffering from bacterial pneumonia |
| |
| Tuberculosis | Patients treated for tuberculosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Characterization of the neutrophil granulocyte epigenome | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 2030 |
| 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). | 2030 |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of demographic and clinical variables | Correlation of demographic and clinical variables (age, sex, disease severity, medication, comorbidities) with epigenetic and functional parameters | 2030 |
| Identification of subgroups within diseases |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tobias Dallenga, Dr. rer. nat. | Contact | +49 4537 188 5561 | tdallenga@fz-borstel.de | |
| Niklas Koehler, Dr. med. | Contact | +49 4537 188 8080 | studienzentrum@fz-borstel.de |
| Name | Affiliation | Role |
|---|---|---|
| Jan Heyckendorf, Prof. Dr. med. | University Hospital Schleswig-Holstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Service Center MVZ, Research Center Borstel, Leibniz Lung Center | Borstel | Schleswig-Holstein | 23845 | Germany |
Individual participant data will be shared upon reasonable request. Please contact the prinicpal investigator.
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Li-heparine plasma
|
| Characterization of the T-cell immune response to to various oxidatively modified mycobacterial antigens | Other | 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. |
|
Exploratory identification of subgroups with characteristic or divergent profiles within the studied patient cohorts
| 2030 |
| Department of Pulmonology, University Hospital Schleswig-Holstein | Kiel | Schleswig-Holstein | 24105 | Germany |
|
| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D018410 | Pneumonia, Bacterial |
| D011024 | Pneumonia, Viral |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D014777 | Virus Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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