Idiopathic Pulmonary Fibrosis and Serum Bank

NCT04016168 | Completed

• 2 other identifiers: 35RC14_97222014-A00268-39
• Study Type: observational
• Target: 903
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial

Keywords

Biomarkers; CD163

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Blood sample collection BIOLOGICAL

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.

Patients with DILD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients seen on an outpatient basis and in stable or acute condition
• Patient over 18 years of age.

You may not qualify if:

• Patients who are unable or unwilling to sign the consent.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital - Service de Pneumologie

Rennes, 35033, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The aim of the study is to set up a biocollection of serum from patients in a context of idiopathic DILD

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stéphane JOUNEAU, MD, PhD

  University Hospital of Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 11, 2019
• Study Start: October 22, 2014
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)