Idiopathic Pulmonary FibrosisFPINCT04016168
Idiopathic Pulmonary Fibrosis and Serum Bank
An observational study of Idiopathic Pulmonary Fibrosis and Lung Diseases, Interstitial, run by Rennes University Hospital at 1 site in France.
Trial summary
Idiopathic pulmonary fibrosis (IPF) is the most common form of chronic idiopathic diffuse interstitial lung disease (DILD) in adults. It is a fibroproliferative, irreversible disease of unknown cause, usually progressive, occurring mainly from the age of 60 and limited to the lungs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial
- What is being tested?
- Blood sample collection
- How many people
- 903 participants
- Where
- 1 siteFrance
- Study dates
- 22 Oct 2014to 28 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited at the consultations of the Rennes Rare Lung Disease Competence Centre. These will be patients in stable condition or in acute exacerbation of IPF.
Who may be able to join
- Patients seen on an outpatient basis and in stable or acute condition
- Patient over 18 years of age.
- The inclusion criteria will be those edited by the American Thoracic Society (ATS) and the European Respiratory Society (ERS) to diagnosis IPF
Who cannot join
- Patients who are unable or unwilling to sign the consent.
Trial locations and contacts
1 site in 1 country.
About this study
Idiopathic pulmonary fibrosis (IPF) is the most common form of chronic idiopathic diffuse interstitial lung disease (DILD) in adults. It is a fibroproliferative, irreversible disease of unknown cause, usually progressive, occurring mainly from the age of 60 and limited to the lungs. IPF is a serious disease with a median survival rate at diagnosis of 3 years.
The aim of the study is to set up a biocollection of serum from patients in a context of idiopathic DILD and a possible or confirmed diagnosis of common interstitial lung disease by chest CT.
Patients will be recruited at the consultations of the Rennes Rare Lung Disease Competence Centre. These will be patients in stable condition or in acute exacerbation of IPF.
Read the detailed description
This study will initially focus on circulating serum CD163 markers, but a broader proteomics approach could be considered in a second phase to look for other markers of lung diseases.
- Being tested
- Blood sample collection
- Keywords
- Biomarkers, CD163
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionBiological
Three additional blood tubes (3 x 8mL) will be collected for this study. They will be added to the traditional diagnostic assessment carried out for their IPF, during their consultation at the competence centre for rare lung diseases. These samples will be taken by a registered nurse in the presence and under the responsibility of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Patients with DILD | Patients will be recruited at the consultations of the Rennes Rare Lung Disease Competence Centre. These will be patients in stable condition or in acute exacerbation of IPF. Receives: Biological: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of circulating CD163 serum concentration
Serum CD163 levels in patients with possible or certain DILD will be performed by ELISA technique (R\&D Systems kit, Minneapolis, MN).
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start22 Oct 2014
- Primary completion28 Dec 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Prospective
- Enrolment
- 903 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane JOUNEAU, MD, PhD, Principal investigator, University Hospital of Rennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016168
- Sponsor's protocol ID
- 35RC14_9722
- Other IDs
- 2014-A00268-39
- Acronym
- FPI
- Status last verified
- Nov 2023
- First submitted
- 8 Jul 2019
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Pulmonary Fibrosis and Serum Bank
- ClinicalTrials.gov ID
- NCT04016168
- Acronym / sponsor ID
- FPI / 35RC14_9722
- Keywords
- Biomarkers, CD163
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 903 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 22 Oct 2014 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 11 Jul 2019 (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.
Idiopathic pulmonary fibrosis (IPF) is the most common form of chronic idiopathic diffuse interstitial lung disease (DILD) in adults. It is a fibroproliferative, irreversible disease of unknown cause, usually progressive, occurring mainly from the age of 60 and limited to the lungs. IPF is a serious disease with a median survival rate at diagnosis of 3 years.
The aim of the study is to set up a biocollection of serum from patients in a context of idiopathic DILD and a possible or confirmed diagnosis of common interstitial lung disease by chest CT.
Patients will be recruited at the consultations of the Rennes Rare Lung Disease Competence Centre. These will be patients in stable condition or in acute exacerbation of IPF.
Detailed description
This study will initially focus on circulating serum CD163 markers, but a broader proteomics approach could be considered in a second phase to look for other markers of lung diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with DILD | – | Biological: Blood sample collectionPatients will be recruited at the consultations of the Rennes Rare Lung Disease Competence Centre. These will be patients in stable condition or in acute exacerbation of IPF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited at the consultations of the Rennes Rare Lung Disease Competence Centre. These will be patients in stable condition or in acute exacerbation of IPF.
Key inclusion criteria (3 listed)
- Patients seen on an outpatient basis and in stable or acute condition
- Patient over 18 years of age.
- The inclusion criteria will be those edited by the American Thoracic Society (ATS) and the European Respiratory Society (ERS) to diagnosis IPF
Key exclusion criteria (1 listed)
- Patients who are unable or unwilling to sign the consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionThree additional blood tubes (3 x 8mL) will be collected for this study. They will be added to the traditional diagnostic assessment carried out for their IPF, during their consultation at the competence centre for rare lung diseases. These samples will be taken by a registered nurse in the presence and under the responsibility of the investigator. | Biological | Patients with DILD |
Primary outcome
Determination of circulating CD163 serum concentration
Time frame: Through study completion, an average of 4 years
Serum CD163 levels in patients with possible or certain DILD will be performed by ELISA technique (R\&D Systems kit, Minneapolis, MN).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- 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.
Stéphane JOUNEAU, MD, PhD principal investigator
University Hospital of Rennes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis and Lung Diseases, Interstitial, run by Rennes University Hospital at 1 site 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determination of circulating CD163 serum concentration (time frame: Through study completion, an average of 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2023.