- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04016168
Idiopathic Pulmonary Fibrosis and Serum Bank (FPI)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Rennes, France, 35033
- Rennes University Hospital - Service de Pneumologie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients who are unable or unwilling to sign the consent.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Determination of circulating CD163 serum concentration
Time Frame: Through study completion, an average of 4 years
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Serum CD163 levels in patients with possible or certain DILD will be performed by ELISA technique (R&D Systems kit, Minneapolis, MN).
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Through study completion, an average of 4 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stéphane JOUNEAU, MD, PhD, University Hospital of Rennes
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC14_9722
- 2014-A00268-39 (Other Identifier: Id-RCB)
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
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