Study for the Validation of the Circuit of Examinations and Analyzes for Better Classification of Airway Diseases

NCT ID: NCT05826522

Last Updated: 2023-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-15

Study Completion Date

2023-12-01

Brief Summary

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ADs (airway diseases) are a group of progressive diseases that lead to a decline of lung function, accelerated by recurrent exacerbations, which can lead to death. ADs include a number of different conditions including asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), bronchiectasis and bronchiolitis frequently related to immune difciency or hematopoietic stem cell transplantations (HSCT), and obstructive chronic lung allograft dysfunction (O-CLAD). The financial burden of ADs is monumental. It is imperative to prevent exacerbations and decline in lung function to reduce ADs mortality and morbidity. The vast amount of knowledge accumulated over the last several years in both biotechnology and digital intelligence, has afforded the evidence of the presence of various treatable traits spread among ADs, that imposes to reassess ADs. BABY-ROAD study proposes to take advantage of these advances to test the feasibility of sampling and exploring ADs patients with multisource data. Baby-ROAD study will be preliminary to the ROAD study that will propose to reclassify ADs into new clusters pertinent for preventive, personalized and participative care.

Detailed Description

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Study population: Patients who are part of the group of ADs. This group of progressive diseases lead to a decline of lung function which is accelerated by recurrent exacerbations, which can in turn lead to death. The study population will include severe asthmatics and asthmatics previously hospitalized at least once in 2016 - 2019, COPD (chronic obstructive pulmonary disease) patients previously hospitalized at least once in 2016 - 2019, cystic fibrosis patients, patients with immunodeficiency with bronchial obstruction, lung transplant recipients with obstructive chronic lung allograft rejection (O-CLAD) and hematopoietic stem cell transplant recipients with bronchial obstruction.

Conditions

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Airway Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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asthmatics and asthmatics previously

observationnal

Intervention Type OTHER

cohort of blood collection and severals exams

COPD (chronic obstructive pulmonary disease) patients

observationnal

Intervention Type OTHER

cohort of blood collection and severals exams

cystic fibrosis patients

observationnal

Intervention Type OTHER

cohort of blood collection and severals exams

patients with immunodeficiency with bronchial obstruction

observationnal

Intervention Type OTHER

cohort of blood collection and severals exams

lung transplant recipients with obstructive chronic lung allograft rejection (O-CLAD)

observationnal

Intervention Type OTHER

cohort of blood collection and severals exams

Interventions

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observationnal

cohort of blood collection and severals exams

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults
* Severe asthmatics + asthmatics previously hospitalized at least once in 2016 - 2019
* COPD patients previously hospitalized at least once in 2016 - 2019 Cystic fibrosis patients, patients with immunodeficiency, without bone marrow transplantation, and with AD determined upon bronchial obstruction (FEV1/FVC \< 70%).
* Lung transplant recipients with obstructive chronic lung allograft rejection (O-CLAD)
* Hematopoietic stem cell transplant recipients with AD determined upon bronchial obstruction.
* Patients already followed-up in pulmonology clinic at the Foch Hospital
* Patients understanding the French language
* Patients having signed an informed consent form prior to any study specific procedure
* Patients being covered by a national health insurance

Exclusion Criteria

* COPD patients previously hospitalized but before 2016
* Immunocompromised patients, having had a bone marrow transplant and suffering from AD determined by bronchial obstruction (FEV1/FVC \> 70%).
* Patients weighing less than 50 kg
* Pregnant women
* Patients who are not followed in pulmonology consultation at Foch Hospital
* Patients don't understanding the French language
* Don't being covered by a national health insurance
* Being deprived of liberty or under guardianship
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2022-A01154-39

Identifier Type: -

Identifier Source: org_study_id

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