Idiopathic Pulmonary Fibrosis and Serum Bank

Idiopathic Pulmonary Fibrosis Clinical Trial

— FPI  

Official title:

Idiopathic Pulmonary Fibrosis and Serum Bank

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04016168
• Other study ID #: 35RC14_9722
• Secondary ID: 2014-A00268-39
• Status: Completed
• Start date: October 22, 2014
• Est. completion date: December 28, 2022

Study information

• Verified date: November 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 903
• Est. completion date: December 28, 2022
• Est. primary completion date: December 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis

Intervention

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.

Locations

Country	Name	City	State
France	Rennes University Hospital - Service de Pneumologie	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Through study completion, an average of 4 years