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Trial record 1 of 1 for:    NCT02574143
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The PROspective German NOn-CF bronchiectaSIS Patient Registry (PROGNOSIS)

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ClinicalTrials.gov Identifier: NCT02574143
Recruitment Status : Unknown
Verified April 2016 by Hannover Medical School.
Recruitment status was:  Recruiting
First Posted : October 12, 2015
Last Update Posted : May 3, 2016
Sponsor:
Collaborators:
CAPNETZ Stiftung
German Center for Lung Research
Information provided by (Responsible Party):
Hannover Medical School

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.

Condition or disease
Bronchiectasis

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

Study Type : Observational [Patient Registry]
Estimated Enrollment : 750 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: The PROspective German NOn-CF bronchiectaSIS Patient Registry
Study Start Date : July 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018



Primary Outcome Measures :
  1. Number of participants with non-CF bronchiectasis (NCFB) across all different levels of health care regarding the current management of NCFB in Germany [ Time Frame: three years ]
    To establish a national, representative, prospective, observational and longitudinal NCFB database and collaborative research network with a database including a minimum of 750 patients from a minimum of 25 centers from all levels of healthcare across Germany after a period of 3 years.


Secondary Outcome Measures :
  1. Prevalence of non-CF bronchiectasis (NCFB) etiologies (composite outcome measures) across all different levels of health care [ Time Frame: three years ]
    • Distribution (prevalence) of underlying conditions/etiologies
    • Clinical presentation of NCFB
    • Predictors of lung function decline in patients with NCFB
    • Diagnostics employed in determining the etiology of NCFB
    • Microbiology of NCFB
    • Radiology of NCFB
    • Comorbidity in patients with NCFB
    • Impact of exacerbations and hospitalizations on the clinical course of NCFB
    • Prescription patterns of pharmacological respiratory treatments for NCFB
    • Usage and benefit of surgical procedures in NCFB
    • Physical therapy and rehabilitation
    • Healthcare utilization and associated costs in NCFB
    • QOL(Questions of Life) among patients with NCFB
    • survival/mortality of NCFB



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with non-CF bronchiectasis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574143


Contacts
Contact: Grit Barten +49 511 5324434 prognosis@capnetz.de

Locations
Germany
Helios Klinikum Emil von Behring - Lungenklinik Heckeshorn Not yet recruiting
Berlin, Germany
Augusta-Kranken-Anstalt Bochum -Klinik für Pneumologie, Beatmungsmedizin und Infektiologie Not yet recruiting
Bochum, Germany
Fachkrankenhaus Coswig Not yet recruiting
Coswig, Germany
Klinik Donaustauf - Zentrum für Pneumologie Not yet recruiting
Donaustauf, Germany
Klinikum Dortmund Medizinische Klinik Nord - Pneumologie, Infektiologie und Internistische Intensivmedizin Not yet recruiting
Dortmund, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden Medizinische Klinik und Poliklinik I, Bereich Pulmologie Not yet recruiting
Dresden, Germany
Florence-Nightingale-Krankenhaus Klinik für Pneumologie, Allergologie, Schlaf- und Beatmungsmedizin Not yet recruiting
Düsseldorf, Germany
Praxis am Maingau Krankenhaus Gemeinschaftspraxis für Innere Medizin, Lungen- und Bronchialheilkunde, Allergologie Not yet recruiting
Frankfurt, Germany
Universitätsklinikum Freiburg Abteilung für Klinische Infektiologie Not yet recruiting
Freiburg, Germany
UKGM - Standort Gießen Medizinische Klinik und Poliklinik II Not yet recruiting
Giessen, Germany
LungenClinic Großhansdorf Not yet recruiting
Großhansdorf, Germany
Medizinische Hochschule Hannover-Klinik für Pneumologie Recruiting
Hannover, Germany
Universitätsklinikum Heidelberg und Thoraxklinik Heidelberg Not yet recruiting
Heidelberg, Germany
Universitätsklinikum Jena Zentrum für Infektionsmedizin und Krankenhaushygiene Not yet recruiting
Jena, Germany
Universitätsklinikum Schleswig-Holstein Medizinische Klinik III - Pneumologie / Infektiologie Not yet recruiting
Lübeck, Germany
Klinikum Lüdenscheid Klinik für Pneumologie, Infektiologie, Schlafmedizin und Internistische Intensivmedizin Not yet recruiting
Lüdenscheid, Germany
Klinikum der Philipps-University Marburg Not yet recruiting
Marburg, Germany
Klinikum der Ludwig-Maximilians-Universität München Not yet recruiting
München, Germany
Diakoniekrankenhaus Rotenburg Zentrum für Pneumologie Not yet recruiting
Rotenburg, Germany
Sponsors and Collaborators
Hannover Medical School
CAPNETZ Stiftung
German Center for Lung Research
Investigators
Study Chair: Jessica Rademacher CAPNETZ STIFTUNG; Medizinische Hochschule Hannover
Study Chair: Felix C. Ringshausen CAPNETZ STIFTUNG; Medizinische Hochschule Hannover
Study Chair: Andrés de Roux Pneumologische Praxis Berlin

Additional Information:
Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT02574143     History of Changes
Other Study ID Numbers: PROGNOSIS
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: April 2016

Keywords provided by Hannover Medical School:
Prognosis
Prospective Study
Quality of Life
Radiology
Rehabilitation
Registry;
Signs and Symptoms
Therapy
Bronchiectiasis
Diagnosis
Epidemiology
Etiology
Longitudinal Study
Microbiology

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases