RaDiCo PID Cohort (RaDiCo-ILD Cohort in English) (RaDiCo-PID)
Idiopathic Interstitial Pneumopathy : Genetic and Environmental Determinants From Infancy to Elderly
Study Overview
Status
Status
Conditions
Conditions
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Marie Chevereau
- Phone Number: + 33 1 71 73 87 94
- Email: marie.chevereau@radico.fr
Study Contact Backup
- Name: Sonia Gueguen
- Phone Number: +33 6 88 34 54 08
- Email: sonia.gueguen@radico.fr
Study Locations
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-
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Bron, France, 69500
- CHU Lyon - Hôpital Louis Pradel
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Paris, France, 75012
- AP-HP - Hôpital Armand Trousseau
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinical criteria: chronic respiratory insufficiency manifestations including dyspnea/tachypnea, cough, and cyanosis during exercise or at rest
- Radiological criteria: characteristic chest High-Resolution Computed Tomography (HRCT) abnormalities including widespread ground glass or alveolar attenuation, reticulation often associated with traction bronchiectasis, and honeycombing
- Functional criteria: pulmonary function test abnormalities reflecting a restrictive pattern and including: loss of lung volume, vital capacity (VC), total lung capacity (TLC); reduction in the diffusion capacity of the lung for carbon monoxide (DLCO), gas exchange abnormalities, and altered ventilatory response to exercise
- Patients (parents/guardians for paediatric/patients) having given an informed consent to participate in the protocol
- Patients affiliated to the "Regime National d'Assurance Maladie"
Exclusion Criteria:
- Patients with diffuse parenchymal lung diseases caused by drug toxicity, immunodeficiency, proliferative disorders including histiocytosis, and metabolic disorders
- Patients (parents/guardians for paediatric patient) not able to approve/understand the protocol
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
|---|
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children or adults with Idiopathic Lung Disease
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The phenotypic description idiopathic lung disease
Time Frame: Up to 10 years
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Phenotypic description will be measure demographic data, environmental data, socio-professionnal data, medical history, comorbidities, clinical examination, biological assessment (hematology; biochemistry; hemostasis...), pulmonary biopsy, bronchial-pulmonary imaging; symptom description; respiratory function (arterial blood gas, pulmonary fonction testing, six minute-walk testing, cardiopulmonary exercise testing, polysomnography), treatments, quality of life questionnaire (SF36 and SF10)
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Up to 10 years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identify gene factors involved in disease initiation and progression
Time Frame: Up to 10 years
|
study genes : SFTPA1, SFTPA2, SFTPB, SFTPC, ABCA3, NKX-2.1,
TERT, TERC, RTEL1, PARN, DKC1, TINF2, COPA, MARS, CSF2RA, CSF2RB, SERPINA1, FLCN
|
Up to 10 years
|
|
Investigate the extent to which environmental and co-morbidity factors may influence disease severity and outcome
Time Frame: Up to 10 years
|
environnemental data: dwellings, wet areas, dust, smoking, drugs, exposure to materials.
Respiratory history, cardiovascular history, endocrinal history, dermatological history, gastroenterology history, gynecology history, haematological history, immune history, neurological history, ophtalmological history, ENT history, psychatric history, Rheumatology history, surgery history
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Up to 10 years
|
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Identify and validate biomarkers for disease diagnosis and progression
Time Frame: Up to 10 years
|
Identify and validate biomarkers for disease diagnosis and progression with Biological assessment (professionnal data, medical history, comorbidities, clinical examination, biological assessment (hematology; biochemistry; hemostasis...) and respiratory function (arterial blood gas, pulmonary fonction testing, six minute-walk testing, cardiopulmonary exercise testing, polysomnography)
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Up to 10 years
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- C15-64
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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