E84 B44
Conditions
Interventions
Group 1: We will screen patients with CF and will enroll eligible patients after written consent in this prospective cohort study.
A medical history questionnaire will be completed and patient sampl
T-cell reactivity of the fungal proteins
- lung function: FEV1, FVC and MEF25
Sponsors
Charite Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
6 Years to 70 Years
Inclusion criteria
Inclusion criteria: -Provide written informed consent - Confirmed diagnosis of CF - Aged between 6 and 70 years - Ability to do a lung function test and to provide sputum samples for microbiological evaluation
Exclusion criteria
Exclusion criteria: Participants will not be entered in the study for any of the following exclusion criteria: - Patients unable to sign informed consent or unwilling to comply with the procedural requirements of this clinical protocol. - No ability to do a lung function test and to provide sputum samples for microbiological evaluation. - Not possible to take blood
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical confirmation of 6 distinct pulmonary aspergillosis stages: 1)Af Colonization 2)Af Sensitization1) 3)Non-allergic bronchopulmonary aspergillosis (Af bronchitis) 4)Allergic bronchopulmonary aspergillosis (ABPA) 5)Invasive pulmonary aspergillosis (Af-pneumonia) 6)Aspergilloma (chronic pulmonary aspergillosis) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Lung function changes based on each of the above mentioned aspergillosis stages - Validated new biomarker(s) indicative for 1) Af Colonization: Af in sputum, qPCR 2) Af Sensitization: Af specific IgG and IgE, Galctomannan Index. 3) Af bronchitis: qPCR in sputum, no increased IgE 4) ABPA: total IgE, Af specific IgE, sputum, Galactomannan Index. 5) Af-pneumonia: T-cell reactivity of the fungal proteins 6) Aspergilloma: sputum, radiological imaging - Characterization of pathogen-Af interaction | — |
Countries
Germany
Contacts
Public ContactCarsten Schwarz
Charité Universitätsmedizin BerlinKlinik für Pädiatrie m.S. Pneumologie und Immunologie Christiane Herzog Zentrum Berlin
Outcome results
None listed