Optimising screening for early disease detection in familial pulmonary fibrosis

Optimising screening for early disease detection in familial pulmonary fibrosis - Screening for early (Famillial) long (LO) fibRosIS (FLORIS)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51138

Enrollment

200

Registered

2021-02-03

Start date

2021-06-16

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

familial lung fibrosis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Subjects must be a first-degree relative of a patient with familial pulmonary fibrosis Subjects are reffered by a medical doctor for screening of familial pulmonary fibrosis

Exclusion criteria

Exclusion criteria: - A previous diagnosis of an interstitial lung disease (ILD) - Pregnancy

Design outcomes

Primary

Measure	Time frame
Presence of Interstitial Lung Disease (ILD) changes on HRCT are indicative of preclinical interstitial lung disease and will be determined at baseline. Putative parameters of early lung disease that will be investigated include lung function, exercise tests, blood based biomarkers, MUC5B rs35705950 genotype, physical examination for digital clubbing and crackles, and self-reported cough and dyspnoea. The primary endpoint is the difference in these parameters between the group with ILD changes on HRCT as compared to the group without ILD changes on HRCT.	—

Measure

Time frame

Presence of Interstitial Lung Disease (ILD) changes on HRCT are indicative of preclinical interstitial lung disease and will be determined at baseline. Putative parameters of early lung disease that will be investigated include lung function, exercise tests, blood based biomarkers, MUC5B rs35705950 genotype, physical examination for digital clubbing and crackles, and self-reported cough and dyspnoea. The primary endpoint is the difference in these parameters between the group with ILD changes on HRCT as compared to the group without ILD changes on HRCT.

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Secondary

Measure	Time frame
The secondary endpoints are differences in values for parameters between the baseline and follow-up screening after one and two years for the ILD changes and no ILD changes cohort and differences between these groups.	—

Countries

Netherlands

Outcome results