NCT04442711

Brief Summary

Extension of the PFBIO cohort which includes patients with newly diagnosed idiopathic pulmonary fibrosis (IPF) for longitudinal follow-up for up to 5 years. In the PFBIO-EXA extension, patients are included if they experience an exacerbation, or other increase in respiratory symptoms requiring hospital admission, for further collection of clinical and biological data.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
32mo left

Started Jun 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jun 2020Dec 2028

First Submitted

Initial submission to the registry

June 13, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 13, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

7.5 years

First QC Date

June 13, 2020

Last Update Submit

December 21, 2023

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

ExacerbationHospitalizationBiomarkersOutcomePrognosisDiagnosis

Outcome Measures

Primary Outcomes (2)

  • Mortality

    All-cause mortality

    30 days

  • Mortality

    All-cause mortality

    90 days

Secondary Outcomes (7)

  • Biomarker levels

    30 days

  • LTOT

    30 days

  • QoL

    30 days

  • Respiratory support

    30 days

  • Decline in functional level

    30 days

  • +2 more secondary outcomes

Study Arms (1)

PFBIO-EXA

All patients recruited for PFBIO-EXA from the original PFBIO cohort are included into the cohort.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients already included in PFBIO that are admitted with a respiratory worsening are eligible for inclusion.

You may qualify if:

  • Admitted with an increase in respiratory symptoms
  • Already included in PFBIO or included simultaneously in PFBIO and PFBIO-EXA
  • Age at least 18 years

You may not qualify if:

  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev and Gentofte Hospital

Hellerup, Copenhagen, 2900, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum and plasma are collected within 24 hrs of hospital admission for measurement of biomarkers.

MeSH Terms

Conditions

Idiopathic Pulmonary FibrosisDisease

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

June 13, 2020

First Posted

June 22, 2020

Study Start

June 13, 2020

Primary Completion (Estimated)

December 1, 2027

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)