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PID (RaDiCo Cohort) (RaDiCo PID)

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ClinicalTrials.gov Identifier: NCT04238871
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary:
The main objective is to describe the phenotypic features of the paediatric and adult patients with Idiopathic Interstitial Pneumopathy/Pneumopathy Interstitial Diffuse (IIP/PID), at diagnosis and during the follow-up. These data will be critical for the description of the natural history of the various forms of IIP/PID.

Condition or disease
Idiopathic Interstitial Pneumopathy/Pneumopathy Interstitial Diffuse Paediatric and Adult Patients

Detailed Description:
The French RaDiCo-IIP/PID (Idiopathic Interstitial Pneumopathy registry is an ongoing observational prospective and retrospective cohort with longitudinal long-term follow-up includes pediatric and adult patients with Idiopathic Interstitial Lung Disesa (ILD) from the reference and competence centers.

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Idiopathic Interstitial Pneumopathy : Genetic and Environmental Determinants From Infancy to Elderly
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : March 27, 2021
Estimated Study Completion Date : September 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Group/Cohort
children or adults with Idiopathic Lung Disease



Primary Outcome Measures :
  1. The phenotypic description idiopathic lung disease [ Time Frame: Up to 10 years ]
    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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with a diagnosis of Pneumopathie Interstitielle Diffuse/ Idiopathic Interstitial Pneumonia diagnosis is established on presenting history, clinical, radiological and functional and if available pathological findings.
Criteria

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

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): NCT04238871


Contacts
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Contact: Marie Chevereau + 33 1 71 73 87 94 marie.chevereau@radico.fr
Contact: Sonia Gueguen +33 6 88 34 54 08 sonia.gueguen@radico.fr

Locations
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France
CHU Lyon - Hôpital Louis Pradel Recruiting
Bron, France, 69500
Contact: Vincent Cottin, Pr       vincent.cottin@chu-lyon.fr   
AP-HP - Hôpital Armand Trousseau Recruiting
Paris, France, 75012
Contact: Annick Clément, Pr       annick.clement@aphp.fr   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT04238871    
Other Study ID Numbers: C15-64
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases