RaDiCo PID Cohort (RaDiCo-ILD Cohort in English)

NCT04238871 | Terminated

• 1 other identifier: C15-64
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 2

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.

Conditions

Idiopathic Interstitial Pneumopathy/Pneumopathy Interstitial Diffuse; Paediatric and Adult Patients

Outcome Measures

Primary Outcomes (1)

• The phenotypic description idiopathic lung disease

  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)

  Up to 10 years

Secondary Outcomes (3)

• Identify gene factors involved in disease initiation and progression

  Up to 10 years

• Investigate the extent to which environmental and co-morbidity factors may influence disease severity and outcome

  Up to 10 years

• Identify and validate biomarkers for disease diagnosis and progression

  Up to 10 years

Study Arms (1)

children or adults with Idiopathic Lung Disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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"

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (2)

CHU Lyon - Hôpital Louis Pradel

Bron, 69500, France

Location

AP-HP - Hôpital Armand Trousseau

Paris, 75012, France

Location

Related Publications (1)

• Cottin V, Gueguen S, Nunes H, Jouneau S, Crestani B, Bonniaud P, Wemeau L, Israel-Biet D, Reynaud-Gaubert M, Gondouin A, Cadranel J, Marchand-Adam S, Chevereau M, Dufaure-Gare I, Amselem S, Clement A; and the RaDiCo team. Treatment of Idiopathic Pulmonary Fibrosis with Capsule or Tablet Formulations of Pirfenidone in the Real-Life French RaDiCo-ILD Cohort. Adv Ther. 2022 Jan;39(1):405-420. doi: 10.1007/s12325-021-01961-x. Epub 2021 Nov 10.

  PMID: 34757602 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: January 23, 2020
• Study Start: June 21, 2017
• Primary Completion: January 19, 2022
• Study Completion: January 19, 2022
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)