Idiopathic Pulmonary Fibrosis and Serum Bank (FPI)

November 27, 2023 updated by: Rennes University Hospital

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

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

903

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • Rennes University Hospital - Service de Pneumologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Biological: Blood sample collection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Through study completion, an average of 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Stéphane JOUNEAU, MD, PhD, University Hospital of Rennes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2014

Primary Completion (Actual)

December 28, 2022

Study Completion (Actual)

December 28, 2022

Study Registration Dates

First Submitted

July 8, 2019

First Submitted That Met QC Criteria

July 10, 2019

First Posted (Actual)

July 11, 2019

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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