Clinical trial NCT02574143: The PROspective German NOn-CF bronchiectaSIS Patient Registry
Official title: The PROspective German NOn-CF bronchiectaSIS Patient Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchiectasis
Keywords: Prognosis
Prospective Study
Quality of Life
Radiology
Rehabilitation
Registry;
Signs and Symptoms
Therapy
Bronchiectiasis
Diagnosis
Epidemiology
Etiology
Longitudinal Study
Microbiology
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: CAPNETZ Stiftung
name: German Center for Lung Research
First posted: 2015-10-12
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-CF bronchiectasis

Brief summary: The purpose of this study is to study the epidemiology of non-CF bronchiectasis (NCFB) and to provide an estimate of the distribution (prevalence) of NCFB etiologies across all different levels of health care as well as real-life data regarding the current management of NCFB in Germany.

Detailed description: * To study the epidemiology of non-CF bronchiectasis (NCFB) and to provide an estimate of the distribution (prevalence) of NCFB etiologies across all different levels of health care as well as real-life data regarding the current management of NCFB in Germany
* To establish feasible investigational strategies in order to establish the etiology of NCFB
* To perform observational research into bronchiectasis, particularly in areas where single center datasets are underpowered, such as in rare etiologies or determining markers of prognosis
* To promote collaborative clinical, basic and translational research in NCFB between German (and European) centers
* To provide a registry of well phenotyped patients with NCFB in clinical centers potentially eligible for enrolment into clinical trials
* To track access to healthcare and cost of caring for patients with NCFB over time

Eligibility criteria: Inclusion Criteria:

* A clinical history consistent with bronchiectasis
* (High resolution) computed tomography (CT) scan of the chest demonstrating bronchiectasis affecting 1 or more lobes

Exclusion Criteria:

* Bronchiectasis due to known cystic fibrosis (CF)
* Age \<18 years
* Interstitial lung disease
* Prior lung or heart-lung transplantation

Primary outcomes:
measure: Number of participants with non-CF bronchiectasis (NCFB) across all different levels of health care regarding the current management of NCFB in Germany
timeFrame: three years
Secondary outcomes:
measure: Prevalence of non-CF bronchiectasis (NCFB) etiologies (composite outcome measures) across all different levels of health care
timeFrame: three years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Helios Klinikum Emil von Behring - Lungenklinik Heckeshorn
city: Bochum
country: Germany
facility: Augusta-Kranken-Anstalt Bochum -Klinik für Pneumologie, Beatmungsmedizin und Infektiologie
city: Coswig
country: Germany
facility: Fachkrankenhaus Coswig
city: Donaustauf
country: Germany
facility: Klinik Donaustauf - Zentrum für Pneumologie
city: Dortmund
country: Germany
facility: Klinikum Dortmund Medizinische Klinik Nord - Pneumologie, Infektiologie und Internistische Intensivmedizin
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden Medizinische Klinik und Poliklinik I, Bereich Pulmologie
city: Düsseldorf
country: Germany
facility: Florence-Nightingale-Krankenhaus Klinik für Pneumologie, Allergologie, Schlaf- und Beatmungsmedizin
city: Frankfurt
country: Germany
facility: Praxis am Maingau Krankenhaus Gemeinschaftspraxis für Innere Medizin, Lungen- und Bronchialheilkunde, Allergologie
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg Abteilung für Klinische Infektiologie
city: Giessen
country: Germany
facility: UKGM - Standort Gießen Medizinische Klinik und Poliklinik II
city: Großhansdorf
country: Germany
facility: LungenClinic Großhansdorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover-Klinik für Pneumologie
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg und Thoraxklinik Heidelberg
city: Jena
country: Germany
facility: Universitätsklinikum Jena Zentrum für Infektionsmedizin und Krankenhaushygiene
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Medizinische Klinik III - Pneumologie / Infektiologie
city: Lüdenscheid
country: Germany
facility: Klinikum Lüdenscheid Klinik für Pneumologie, Infektiologie, Schlafmedizin und Internistische Intensivmedizin
city: Marburg
country: Germany
facility: Klinikum der Philipps-University Marburg
city: München
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universität München
city: Rotenburg
country: Germany
facility: Diakoniekrankenhaus Rotenburg Zentrum für Pneumologie
Study officials:
affiliation: CAPNETZ STIFTUNG; Medizinische Hochschule Hannover
name: Jessica Rademacher
role: STUDY_CHAIR
affiliation: CAPNETZ STIFTUNG; Medizinische Hochschule Hannover
name: Felix C. Ringshausen
role: STUDY_CHAIR
affiliation: Pneumologische Praxis Berlin
name: Andrés de Roux
role: STUDY_CHAIR
References: