NCT07419555

Brief Summary

Currently, it remains unclear how to manage serial lung function measurements in a clinical setting. The investigators aimed to tackle this problem by developing a machine learning (ML) model that can accurately predict population and individual lung function trajectories. These predictions would enable the investigators to identify positive or negative deviations, thereby revealing unexpected disease patterns. A prospective validation is needed that includes data on mortality, hospitalisations, emergency-room visits and patient-reported outcomes. Within this study, the goal is to validate the ML model with the data collected from this observational study.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Mar 2026Mar 2029

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 25, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

February 12, 2026

Last Update Submit

March 25, 2026

Conditions

Chronic Respiratory Diseases

Keywords

lung functiontrajectorypredictions

Outcome Measures

Primary Outcomes (1)

  • Accuracy of lung function predictions (FEV1)

    Proportion of correct and incorrect FEV1 predictions compared to the observed measure

    at 1 and 2-year follow-up

Secondary Outcomes (6)

  • Differences in clinical outcomes between correct and incorrect lung function predictions (FEV1)

    at 1 and 2-year follow-up

  • Accuracy of lung function predictions

    at 1 and 2-year follow-up

  • Differences in clinical outcomes between correct and incorrect lung function predictions

    at 1 and 2-year follow-up

  • Identifying the minimal needed to make predictions

    after 2 years

  • Performance of ML-based predictions compared to linear regression analysis

    at 1 and 2-year follow-up

  • +1 more secondary outcomes

Eligibility Criteria

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

Chronic respiratory diseases

You may qualify if:

  • Above 18 years old
  • Diagnosed with a chronic respiratory disease and followed up in one of the participating Belgian hospitals
  • Performed a complete lung function test (spirometry, body plethysmography and diffusion capacity) at baseline
  • Planned routine follow-up within standard clinical care in one of the participating hospitals

You may not qualify if:

  • Patients who have had a lung transplantation
  • Patients not being able to give consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UZ Antwerpen

Edegem, 2650, Belgium

NOT YET RECRUITING

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

NOT YET RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

AZ Delta

Roeselare, 8800, Belgium

NOT YET RECRUITING

Study Officials

  • Wim Janssens

    UZ/KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marieke Wuyts

CONTACT

016 34 31 59marieke.wuyts@kuleuven.be

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

February 12, 2026

First Posted

February 19, 2026

Study Start

March 25, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

BE(4)