PFBIO-HP: Database and Biobank of Patients With Hypersensitivity Pneumonitis

Sponsor

Nils Hoyer (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05549635

Collaborator

(none)

Enrollment

75.4

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypersensitivity Pneumonitis

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Pulmonary Fibrosis Biobank - Hypersensitivity Pneumonitis

Anticipated Study Start Date :

Sep 18, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life questionnaires [3 years]
SGRQ
Pulmonary function test [3 years]
FVC
Pulmonary function test [3 years]
DLCO
Imaging [3 years]
HRCT scans

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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