Idiopathic Interstitial Pneumopathy/Pneumopathy Interstitial DiffuseRaDiCo-PIDNCT04238871
RaDiCo PID Cohort (RaDiCo-ILD Cohort in English)
An observational study of Idiopathic Interstitial Pneumopathy/Pneumopathy Interstitial Diffuse and Paediatric and Adult Patients, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Interstitial Pneumopathy/Pneumopathy Interstitial Diffuse, Paediatric and Adult Patients
- How many people
- 1,600 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Jun 2017to 19 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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"
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Lyon - Hôpital Louis Pradel
Bron, 69500
AP-HP - Hôpital Armand Trousseau
Paris, 75012
About this study
Official title: Idiopathic Interstitial Pneumopathy : Genetic and Environmental Determinants From Infancy to Elderly
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.
Read the detailed description
The French RaDiCo-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 Disease (ILD) from the reference and competence centers.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| children or adults with Idiopathic Lung Disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 10 years
Secondary outcomes (3)
Identify gene factors involved in disease initiation and progression
study genes : SFTPA1, SFTPA2, SFTPB, SFTPC, ABCA3, NKX-2.1, TERT, TERC, RTEL1, PARN, DKC1, TINF2, COPA, MARS, CSF2RA, CSF2RB, SERPINA1, FLCN
Measured: Up to 10 years
Investigate the extent to which environmental and co-morbidity factors may influence disease severity and outcome
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
Measured: Up to 10 years
Identify and validate biomarkers for disease diagnosis and progression
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)
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start21 Jun 2017
- Primary completion19 Jan 2022
- Study completion19 Jan 2022
Why it stopped: Regulatory requalification en C20-58
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Interstitial Pneumopathy/Pneumopathy Interstitial DiffuseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238871
- Sponsor's protocol ID
- C15-64
- Acronym
- RaDiCo-PID
- Status last verified
- Apr 2026
- First submitted
- 25 Nov 2019
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34757602
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Interstitial Pneumopathy : Genetic and Environmental Determinants From Infancy to Elderly
- ClinicalTrials.gov ID
- NCT04238871
- Acronym / sponsor ID
- RaDiCo-PID / C15-64
- Conditions
- Idiopathic Interstitial Pneumopathy/Pneumopathy Interstitial Diffuse, Paediatric and Adult Patients
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Regulatory requalification en C20-58
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The French RaDiCo-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 Disease (ILD) from the reference and competence centers.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children or adults with Idiopathic Lung Disease | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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"
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
3 secondary outcomes
Identify gene factors involved in disease initiation and progression
Time frame: 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
Identify and validate biomarkers for disease diagnosis and progression
Time frame: Up to 10 years
Results and safety
The study was stopped early (reason given: Regulatory requalification en C20-58). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Results publication: PubMed 34757602Cottin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Interstitial Pneumopathy/Pneumopathy Interstitial Diffuse and Paediatric and Adult Patients, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Regulatory requalification en C20-58). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The phenotypic description idiopathic lung disease (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04238871, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.