- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04187079
Immunopathologic Profiles and Blood Biomarkers in Patients With IPF
Immunopathologic Profiles of the Lung Micro- Environment Using Cryobiopsies and Identification of Blood Biomarkers in Patients With IPF
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.
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aarhus, Denmark, 8000
- Aarhus University Hospital, Department of Respiratory Diseases and Allergy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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IPF
Patients diagnosed with idiopathic pulmonary fibrosis after multidisciplinary team discussion using medical history, HRCT pattern, laboratory findings, pulmonary function tests and cryobiopsy specimens.
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Other ILDs
Patients diagnosed with other interstitial diseases other than IPF after multidisciplinary team discussion using medical history, HRCT pattern, laboratory findings, pulmonary function tests and cryobiopsy specimens.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PD-L1
Time Frame: At diagnosis
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Expression of PD-L1 in the epithelial cells in lungs
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At diagnosis
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Venerino Poletti, Prof, Department of Respiratory Diaseses, Aarhus University Hospital
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cryobiopsy in IPF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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