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PROOF-Registry New and Extended Belgium -Luxembourg

Study Purpose

A Prospective Observational Registry to describe the disease course and outcomes of Idiopathic Pulmonary Fibrosis patients in a real-world clinical setting.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients >18 years of age.
  • - IPF diagnosis "definite" or "probable" (2011 ATS/ERS guidelines definitions) confirmed by a multidisciplinary team (= minimum of pulmonologist, radiologist, pathologist, all with expertise in IPF).
  • - Patients who agreed to participate in the registry and have completed and signed the Informed Consent Form.

Exclusion Criteria:

  • - Patients incapable of giving informed consent.
- Patients participating in a clinical trial at the time of inclusion in the registry and whose protocol does not allow participation in another trial

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03732859
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Belgian Thoracic Society
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Wim Wuyts, Phd, MD
Principal Investigator Affiliation Universitaire Ziekenhuizen Leuven
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries Belgium, Luxembourg
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Additional Details

Idiopathic pulmonary fibrosis (IPF) is a chronic disease of unknown etiology, characterized by scar tissue (fibrosis) within the lungs. IPF is one of the most common forms of interstitial lung disease and is associated with substantial morbidity and mortality (average survival of approximately three years from the time of diagnosis)). The epidemiology and natural history of IPF is still not completely understood. Incidence and prevalence of IPF are difficult to determine because uniform diagnostic criteria have only recently been defined. Recent data among subjects aged 50 years or older suggests an age- and sex-adjusted incidence rate ranging from 8.8 cases to 17.4 cases per 100,000 person-years in the USA. In the same population, age- and sex- adjusted prevalence ranged from 27.9 cases to 63 cases per 100,000 persons. Familial form of IPF accounts for 0.5 to 2% of all cases of IPF. Several environmental or occupational exposures seem to be prevalent in the medical histories of patients diagnosed with the disease. The onset of IPF symptoms is slow, but symptoms become progressively worse over time. Breathlessness upon exertion and chronic dry cough are the major symptoms. Gastro-esophageal acid reflux is present in almost 90% of patients with IPF but often occurs without symptoms. Auscultation of the lungs reveals early inspiratory crackles, predominantly located in the lower posterior lung zones upon physical exam. Clubbing is found in approximately 50% of patients with IPF. Quality of life of patients with IPF is impacted by the disease. Establishing an accurate diagnosis for the patient who presents with interstitial lung disease is an essential component of management. The recent ATS/ERS/JRS/ALAT recommendations on the diagnosis and management of IPF were developed from a systematic review of the published literature. High-resolution computed tomography (HRCT) scanning has a central role in the IPF diagnostic pathway with formal designation of criteria for an HRCT pattern of Usual Interstitial Pneumonia (UIP). In the correct clinical context, a UIP pattern on HRCT is indicative of a definite diagnosis of IPF without the need for a surgical lung biopsy. IPF presents significant associations with other cardiopulmonary disorders including coronary artery disease, pulmonary embolism, sleep apnea, respiratory infections and lung cancer. In addition, patients with IPF are at risk for 'acute exacerbations'. Acute exacerbation is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality. Diagnostic criteria are: previous or concurrent diagnosis of IPF; acute worsening or development of dyspnea typically < 1 mo duration; computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern; deterioration not fully explained by cardiac failure or fluid overload. These acute exacerbations are responsible for 50% of deaths in IPF and may affect previously stable patients. The clinical course of IPF is highly variable and as a result, therapeutic strategies should be highly individualized, based upon the specific patients' medical history and co-morbidities. Pirfenidone and Nintedanib are drugs approved for the treatment of adult patients with mild to moderate idiopathic pulmonary fibrosis in the European Union. In order to complement the data collected in previous studies, we implement a registry to describe the epidemiology and natural history of IPF, as well as the quality of life of IPF patients, and use of health care resources, in Belgium and Luxembourg. This registry will also enable the collection of clinical data of patients treated with Pirfenidone or Nintedanib and other therapies used in the treatment of IPF. The registry will be implemented in collaboration with pulmonologists and expert centers in order to enable the inclusion and follow up of recently diagnosed IPF patients.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ziekenhuisnetwerk Antwerpen vzw, Antwerp, Belgium

Status

Recruiting

Address

Ziekenhuisnetwerk Antwerpen vzw

Antwerp, , 2000

Site Contact

Maaike Viaene

maaike.viaene@zna.be

+32 (0)470557178

Brussels, Belgium

Status

Recruiting

Address

Cliniques Universitaires de Bruxelles - Hôpital Erasme

Brussels, , 1070

Site Contact

Liliane Collignon

Liliane.Collignon@erasme.ulb.ac.be

+32 2 555 35 51

Cliniques universitaires Saint-Luc, Brussels, Belgium

Status

Recruiting

Address

Cliniques universitaires Saint-Luc

Brussels, , 1200

Site Contact

Sandra Koenig

sandra.koenig@uclouvain.be

+32 (0)470557178

Universitair Ziekenhuis Gent, Ghent, Belgium

Status

Recruiting

Address

Universitair Ziekenhuis Gent

Ghent, , 9000

Site Contact

Anja Delporte

anja.delporte@uzgent.be

+32(0)93320228

University Hospitals Leuven, Leuven, Belgium

Status

Recruiting

Address

University Hospitals Leuven

Leuven, , 3000

Site Contact

Lieve Bruggeman

lieve.bruggeman@uzleuven.be

+32 (0)470557178

Liège, Belgium

Status

Recruiting

Address

Centre Hospitalier Universitaire Sart Tilman

Liège, , 4000

Site Contact

Anne Chevremont, MD

lieve.bruggeman@uzleuven.be

+32 (0)470557178

CHR de la Citadelle, Liège, Belgium

Status

Recruiting

Address

CHR de la Citadelle

Liège, , 4000

Site Contact

Michel Crine

Michel.crine@chrcitadelle.be

+32 4 225 70 47

CHU UCL Namur asbl - site Godinne, Yvoir, Belgium

Status

Recruiting

Address

CHU UCL Namur asbl - site Godinne

Yvoir, , 5530

Site Contact

Emilie Collet

emilie.collet@uclouvain.be

+32 81 42 30 28

Luxembourg, Luxembourg

Status

Recruiting

Address

Centre Hospitalier de Luxembourg (CHL)/ Luxembourg Institute of Health (LIH)

Luxembourg, , 1210

Site Contact

Gloria Montanes

Gloria.Montanes@lih.lu

+32 (0)470557178