Database and Biobank of Patients With Hypersensitivity Pneumonitis (PFBIO-HP)

December 21, 2023 updated by: Nils Hoyer

Pulmonary Fibrosis Biobank - Hypersensitivity Pneumonitis

Sub-study of the main Pulmonary Fibrosis Biomarker (PFBIO) cohort (NCT02755441), recruiting patients with an MDT-diagnosis of hypersensitivity pneumonitis (HP). Patients are included for the collection of blood samples and regular clinical data.

The database and biobank will be available for studies of HP, and can be directly compared to the main PFBIO cohort, which has recruited patients with Idiopathic pulmonary Fibrosis (IPF) since 2016.

Biomarkers will be assessed as diagnostic and prognostic. Further subtyping of HP, based on blood markers (including precipitins) will also be possible with the PFBIO-HP project.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
    • Copenhagen
      • Hellerup, Copenhagen, Denmark, 2900
        • Recruiting
        • Department of Respiratory Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All adult patients with an MDT-diagnosis of HP are eligible.

Description

Inclusion Criteria:

  • Diagnosis of HP at an MDT conference according to the current international guidelines
  • Age of 18 years or older
  • The patients must be capable of giving informed consent

Exclusion Criteria:

- Unable to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients with an MDT-diagnosis of hypersensitivity pneumonitis (HP)

The overall inclusion criteria of patients in the HP cohort are:

  • Diagnosis of HP at an MDT conference according to the current international guidelines
  • Age of 18 years or older
  • The patients must be capable of giving informed consent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of HP
Time Frame: 0 days
MDT-Diagnosis of HP
0 days
Exposure to inciting antigen (patient reported)
Time Frame: 0 days
Known exposure, as reported by the patient
0 days
Exposure to inciting antigen (measurable)
Time Frame: 0 days
Measurable exposure, as tested by precipitins
0 days
Progression free survival
Time Frame: 3 years
Survival without progression
3 years
Overall survival
Time Frame: 3 years
Survival after diagnosis
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life questionnaires
Time Frame: 3 years
SGRQ
3 years
Pulmonary function test
Time Frame: 3 years
FVC
3 years
Pulmonary function test
Time Frame: 3 years
DLCO
3 years
Imaging
Time Frame: 3 years
HRCT scans
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nils Hoyer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2022

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

September 16, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PFBIO-HP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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