Idiopathic Pulmonary FibrosisNCT04187079
Immunopathologic Profiles and Blood Biomarkers in Patients With IPF
An observational study of Idiopathic Pulmonary Fibrosis, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Sep 2017to 27 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suspected of having an ILD who are having cryobiopsies performed to get a histological specimen for the diagnoses.
Who may be able to join
- Patients suspected of having an ILD who are having cryobiopsies performed
Who cannot join
- BMI > 35
- DLCO < 35%
- FVC < 45%
- Pulmonary hypertension
- Cardiac or other severe comorbidity that will increase the risk of complications
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Department of Respiratory Diseases and Allergy
Aarhus, 8000
About this study
Official title: 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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD-L1
Expression of PD-L1 in the epithelial cells in lungs
Measured: At diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start18 Sep 2017
- Primary completion1 May 2019
- Study completion27 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Venerino Poletti, Prof, Principal investigator, Department of Respiratory Diaseses, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187079
- Sponsor's protocol ID
- Cryobiopsy in IPF
- Status last verified
- Jul 2021
- First submitted
- 2 Dec 2019
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunopathologic Profiles of the Lung Micro- Environment Using Cryobiopsies and Identification of Blood Biomarkers in Patients With IPF
- ClinicalTrials.gov ID
- NCT04187079
- Acronym / sponsor ID
- Cryobiopsy in IPF
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suspected of having an ILD who are having cryobiopsies performed to get a histological specimen for the diagnoses.
Key inclusion criteria (1 listed)
- Patients suspected of having an ILD who are having cryobiopsies performed
Key exclusion criteria (5 listed)
- BMI > 35
- DLCO < 35%
- FVC < 45%
- Pulmonary hypertension
- Cardiac or other severe comorbidity that will increase the risk of complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PD-L1
Time frame: At diagnosis
Expression of PD-L1 in the epithelial cells in lungs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Venerino Poletti, Prof principal investigator
Department of Respiratory Diaseses, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PD-L1 (time frame: At diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.