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CompletedNCT03264417Updated Sep 5, 2018

Pulmonary Function Test Study - Automated Interpretation

An observational study in Respiratory Disease, sponsored by KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by KU Leuven · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 21 studies in Respiration Disorders with a site in Belgium — none open to participants now, 2 under way, none of them phase 3. Respiration Disorders · Belgium.

Started
2017
with 3 others
Observational
7 of 21
none open now
Registered
11th of 21
by date
Lead sponsor
3 of 21
KU Leuven

Among the 21 studies in Respiration Disorders with a site in Belgium, this one is one of 4 that started in 2017, is one of 7 observational ones, and was the 11th registered.

Respiration Disorders

359 studies on the registry are indexed under Respiration Disorders; 64 are open to participants now.

Browse Respiration Disorders studies →

Open to participants now

None of the 21 studies in Respiration Disorders with a site in Belgium is open now. The open studies under Respiration Disorders, anywhere →

Who these studies take

Of the 45 Respiration Disorders studies recruiting now, 27 (60%) set no upper age limit and 13 (29%) stop at 75 or younger; 15 take children under 18; 21 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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Download CSVNarrow it in search →With an account: the 21 studies in Respiration Disorders with a site in Belgium as a file.
02

Study summary

A multicentric study to explore variability when clinicians are intrepreting lung function tests. Comparison with results of in-house built software for automatic interpretation.

Read the detailed description

This is a multi-center non-interventional retrospective study that will use data obtained from clinical routine. In the hospital, subjects with or without respiratory complaints undergo subset of (or complete) pulmonary function tests if clinically indicated. Results of these tests, expressed as numerical values are send to the clinical workstation (KWS) for immediate clinical use. These results are subsequently being interpreted by a clinician.

A random sample of 50 lung function printouts of subjects followed at the Leuven pulmonary service with a final diagnosis of a respiratory disease have been randomised. These anonymized printouts will be given to different pulmonologists for examination in 18 different centers and compared with the interpretation of in-house developed software.

03

Conditions studied

  • Respiratory Disease

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects with or without respiratory complaints undergo subset of (or complete) pulmonary function tests

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age more than 18 years
  2. Completed one or more pulmonary function tests

Exclusion criteria

Exclusion Criteria:

  1. Younger than 18
  2. Lung transplantation, lung cancer.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
50 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Interclass correlation coëfficiënt for whole group

    Variation in preferred primary diagnosis of respiratory disease given by every physician for every case (selection of one diagnosis out of a fixed panel of 9 possible diagnoses).

    Time frame: 6 months

Secondary outcomes

  1. Interclass correlation coëfficiënt for every case

    Variation in preferred primary diagnosis of respiratory disease given by every physician for an individual case (selection of one diagnosis out of a fixed panel of 9 possible diagnoses).

    Time frame: 6 months

  2. Accuracy of physicians expressed as a percentage of correct diagnoses per case (%)

    Comparison of diagnostic labels per case provided by the physicians with gold standard diagnosis based on clinical characteristics, complete pulmonary function test data and all other investigations (CT scan, biochmestry, functional test, biopsy, etc...) needed to come to a gold standard diagnosis.

    Time frame: 6 months

  3. Accuracy of physicans expressed as a percentage of correct diagnoses in total group (%)

    Comparison of diagnostic labels per case provided by the physicians with gold standard diagnosis based on clinical characteristics, complete pulmonary function test data and all other investigations (CT scan, biochmestry, functional test, biopsy, etc...) needed to come to a gold standard diagnosis.

    Time frame: 6 months

  4. Accuracy of physicians expressed as a percentage of correct diagnoses per hospital (group) (%)

    Comparison of diagnostic labels per case provided by the group of physicians per hospital with gold standard diagnosis based on clinical characteristics, complete pulmonary function test data and all other investigations (CT scan, biochmestry, functional test, biopsy, etc...) needed to come to a gold standard diagnosis.

    Time frame: 6 months

  5. Accuracy of software expressed as a percentage of correct diagnoses in total group, per hospital and per case

    Comparing labels of in-house developed software for the clinical interpretation and diagnostic labeling of complete pulmonary function tests with GOLD standard based on all additional tests

    Time frame: 6 months

  6. Comparison of accuracy (% of correct diagnoses) of physicians with software

    Comparing the diagnostic labels provided by in-house developed software for the clinical interpretation and diagnostic labeling of complete pulmonary function tests with those of physicans (in total group, per hospital and per case)

    Time frame: 6 months

07

Study locations

1 site
  • UZ Leuven
    Leuven, 3000, Belgium
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2017 to primary completion in Dec 2017, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2017
First posted
Aug 29, 2017
StartActual
Aug 1, 2017
Primary completionActual
Dec 30, 2017
CompletionActual
Apr 1, 2018
Last update
Sep 5, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03264417
Lead sponsor
KU Leuven
Collaborators
University Hospital, Ghent, AZ Sint-Jan AV, Ziekenhuis Oost-Limburg, Jessa Hospital, Onze Lieve Vrouwziekenhuis Aalst, Centre Hospitalier Universitaire de Charleroi, University Hospital St Luc, Brussels, Centre Hospitalier Universitaire Saint Pierre, University of Liege, Centre Hospitalier du Luxembourg, Maastricht University Medical Center, University Medical Center Nijmegen, University Medical Center Groningen, University Hospital, Paris, University Hospital, Grenoble, Philipps University Marburg
Responsible party
Wim Janssens (Prof. Dr., KU Leuven) — Principal investigator
First posted
Aug 29, 2017
Start date
Aug 1, 2017
Primary completion
Dec 30, 2017
Completion
Apr 1, 2018
Last update
Sep 5, 2018

Study contacts

Wim Janssens, Prof. Dr.
principal investigator · UZ Leuven

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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