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
1 other identifier
observational
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
December 2, 2019
CompletedFirst Posted
Study publicly available on registry
December 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 27, 2021
CompletedAugust 10, 2021
July 1, 2021
1.6 years
December 2, 2019
August 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
PD-L1
Expression of PD-L1 in the epithelial cells in lungs
At diagnosis
Study Arms (2)
IPF
Patients diagnosed with idiopathic pulmonary fibrosis after multidisciplinary team discussion using medical history, HRCT pattern, laboratory findings, pulmonary function tests and cryobiopsy specimens.
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.
Eligibility Criteria
Patients suspected of having an ILD who are having cryobiopsies performed to get a histological specimen for the diagnoses.
You may qualify if:
- Patients suspected of having an ILD who are having cryobiopsies performed
You may not qualify if:
- BMI \> 35
- DLCO \< 35%
- FVC \< 45%
- Pulmonary hypertension
- Cardiac or other severe comorbidity that will increase the risk of complications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
Study Sites (1)
Aarhus University Hospital, Department of Respiratory Diseases and Allergy
Aarhus, 8000, Denmark
Biospecimen
Plasma Cryobiopsies
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Venerino Poletti, Prof
Department of Respiratory Diaseses, Aarhus University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2019
First Posted
December 5, 2019
Study Start
September 18, 2017
Primary Completion
May 1, 2019
Study Completion
July 27, 2021
Last Updated
August 10, 2021
Record last verified: 2021-07