Database and Biobank of Patients With Hypersensitivity Pneumonitis

NCT05549635 | Recruiting

• 1 other identifier: PFBIO-HP
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypersensitivity Pneumonitis

Keywords

biomarker; prognosis; diagnosis; phenotyping; genotyping

Outcome Measures

Primary Outcomes (5)

• Diagnosis of HP

  MDT-Diagnosis of HP

  0 days

• Exposure to inciting antigen (patient reported)

  Known exposure, as reported by the patient

  0 days

• Exposure to inciting antigen (measurable)

  Measurable exposure, as tested by precipitins

  0 days

• Progression free survival

  Survival without progression

  3 years

• Overall survival

  Survival after diagnosis

  3 years

Secondary Outcomes (4)

• Quality of life questionnaires

  3 years

• Pulmonary function test

  3 years

• Pulmonary function test

  3 years

• Imaging

  3 years

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- Unable to sign informed consent

Sponsors & Collaborators

• Nils Hoyer: lead

Study Sites (1)

Department of respiratory medicine

Hellerup, Copenhagen, 2900, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

There will be collected serum, EDTA plasma and DNA from included subjects.

MeSH Terms

Conditions

Alveolitis, Extrinsic Allergic; Disease

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nils Hoyer, PhD

CONTACT

+45-3867 4200; nils.hoyer@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: September 22, 2022
• Study Start: September 18, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)