Respiratory DiseaseNCT03264417
Pulmonary Function Test Study - Automated Interpretation
An observational study of Respiratory Disease, run by KU Leuven at 1 site in Belgium.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disease
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2017to 1 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with or without respiratory complaints undergo subset of (or complete) pulmonary function tests
Who may be able to join
- Age more than 18 years
- Completed one or more pulmonary function tests
Who cannot join
- Younger than 18
- Lung transplantation, lung cancer.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Respiratory Disease
- Medical subject headings
- Respiration Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (6)
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).
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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
Measured: 6 months
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Aug 2017
- Primary completion30 Dec 2017
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Wim Janssens, KU Leuven
- Investigators
- Wim Janssens, Prof. Dr., Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264417
- Sponsor's protocol ID
- S60619
- Status last verified
- Sep 2018
- First submitted
- 1 Aug 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Function Test Study - Automated Interpretation
- ClinicalTrials.gov ID
- NCT03264417
- Acronym / sponsor ID
- S60619
- Conditions
- Respiratory Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- 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
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicentric study to explore variability when clinicians are intrepreting lung function tests. Comparison with results of in-house built software for automatic interpretation.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with or without respiratory complaints undergo subset of (or complete) pulmonary function tests
Key inclusion criteria (2 listed)
- Age more than 18 years
- Completed one or more pulmonary function tests
Key exclusion criteria (2 listed)
- Younger than 18
- Lung transplantation, lung cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interclass correlation coëfficiënt for whole group
Time frame: 6 months
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).
6 secondary outcomes
Interclass correlation coëfficiënt for every case
Time frame: 6 months
Accuracy of physicians expressed as a percentage of correct diagnoses per case (%)
Time frame: 6 months
Accuracy of physicans expressed as a percentage of correct diagnoses in total group (%)
Time frame: 6 months
Accuracy of physicians expressed as a percentage of correct diagnoses per hospital (group) (%)
Time frame: 6 months
Accuracy of software expressed as a percentage of correct diagnoses in total group, per hospital and per case
Time frame: 6 months
Comparison of accuracy (% of correct diagnoses) of physicians with software
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wim Janssens, Prof. Dr. principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Disease, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interclass correlation coëfficiënt for whole group (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.