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NCT04187079 Clinical Trial

Immunopathologic Profiles and Blood Biomarkers in Patients With IPF

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:
Immunopathologic Profiles of the Lung Micro- Environment Using Cryobiopsies and Identification of Blood Biomarkers in Patients With IPF

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04187079
Other study ID # Cryobiopsy in IPF
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 18, 2017
Est. completion date July 27, 2021

Study information
Verified date July 2021
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Examination of expression of PD-L1, PD-L2, Beta- catenin, B-cell follicles and Tenascin- C in patients with IPF compared with other interstitial lung diseases. Examination of anti HSP 70, p-ANCA, c-ANCA, CD4+/CD28- and CD8+/CD28- cells in patients with IPF compared with other interstitial lung diseases. Compare the above mentioned findings with changes in pulmonary function tests, 6 minute walking test, exacerbation and mortality over a 2 year follow-up period.

Description:

Examination of expression of PD-L1, PD-L2, Beta- catenin, B-cell follicles and Tenascin- C in cryobiopsies from the lungs inpatients with IPF compared with other interstitial lung diseases. Examination of anti HSP 70, p-ANCA, c-ANCA, CD4+/CD28- and CD8+/CD28- cells in blood samples in patients with IPF compared with other interstitial lung diseases. Compare the above mentioned findings with changes in pulmonary function tests, 6 minute walking test, exacerbation and mortality over a 2 year follow-up period.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date July 27, 2021
Est. primary completion date May 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients suspected of having an ILD who are having cryobiopsies performed Exclusion Criteria: - BMI > 35 - DLCO < 35% - FVC < 45% - Pulmonary hypertension - Cardiac or other severe comorbidity that will increase the risk of complications

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Aarhus University Hospital, Department of Respiratory Diseases and Allergy Aarhus

Sponsors (2)
Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary PD-L1 Expression of PD-L1 in the epithelial cells in lungs At diagnosis
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