Pulmonary FibrosisILDnoseNCT04680832
Exhaled Breath Analysis Using eNose Technology as a Biomarker for Diagnosis and Disease Progression in Fibrotic ILD
An observational study of Pulmonary Fibrosis, run by Erasmus Medical Center at 5 sites in 5 countries.
Trial summary
The ILDnose study a multinational, multicenter, prospective, longitudinal study in outpatients with pulmonary fibrosis. The aim is to assess the accuracy of eNose technology as diagnostic tool for diagnosis and differentiation between the most prevalent fibrotic interstitial lung diseases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- Electronic nose
- How many people
- 600 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Nov 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with ILD
Who may be able to join
- Patients with a diagnosis of fibrotic ILD, as discussed in a multidisciplinary team meeting (50% incident patients and 50% prevalent patients). Patients are classified as 'incident' if they received a diagnosed in a multidisciplinary team meeting within the past six months. Patients will be required to have fibrosis on a HRCT scan <1 year before enrollment in the study defined as reticular abnormality with traction bronchiectasis, with or without honeycombing, as determined by a radiologist. No minimum extent of fibrosis will be required.
Who cannot join
- Alcohol consumption ≤ 12 hours before the measurement
- Physically not able to perform eNose measurement
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Australia1 site
Royal Prince Alfred Hospital
Camperdown, New South Wales, NSW 2050
France1 site
University Lyon 1, Louis Pradel hospital, Lyon. FranceService de pneumologie, hôpital Louis Pradel
Lyon
About this study
Official title: Exhaled Breath Analysis Using eNose Technology as a Biomarker for Diagnosis and Disease Progression in Fibrotic Interstitial Lung Disease
The ILDnose study a multinational, multicenter, prospective, longitudinal study in outpatients with pulmonary fibrosis. The aim is to assess the accuracy of eNose technology as diagnostic tool for diagnosis and differentiation between the most prevalent fibrotic interstitial lung diseases. The value of eNose as biomarker for disease progression and response to treatment is also assessed. Besides, validity of several questionnaires for pulmonary fibrosis is investigated.
Read the detailed description
Patients will be included in the study after signing written informed consent. eNose measurements will take place before or after a routine outpatient clinic visit at the same location as the regular visit, ensuring minimal inconvenience for patients. First, patients will be asked to rinse their mouth thoroughly with water three times. Subsequently, exhaled breath analysis will be performed in duplicate with a 1-minute interval. An eNose measurement consists of five tidal breaths, followed by an inspiratory capacity maneuver to total lung capacity, a five second breath hold, and subsequently a slow expiration (flow <0.4L/s) to residual volume. The measurements are non-invasive and will cost approximately 5-10 minutes in total, including explanation and informed consent procedure. There are no risks associated with this study and the burden for patients is minimal.
After the measurement, patients will complete a short survey about questions relevant for the data analysis (food intake in the last two hours, smoking history, medication use, comorbidities, and symptoms of respiratory infection). In addition, patients will complete the L-PF questionnaire and the Global Rating of Change scale (GRoC). The L-PF questionnaire consists of 21 questions on a 5-point Likert scale about the impact of pulmonary fibrosis on quality of life, and takes about 3 minutes to complete. The GRoC consists of one question on a scale from -7 to 7: were there any changes in your quality of life since your last visit? Symptoms (cough and dyspnea) will be scored on a 10 cm VAS scale from -5 to 5.
Next to eNose measurements, demographic data and physiological parameters of patients will be collected from the medical records at baseline, month 6, and month 12. Parameters such as age, gender, diagnosis, time since diagnosis, comorbidities, medication, pulmonary function (forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO)), laboratory parameters (i.e. auto-immune antibodies), HRCT pattern, BAL results and if applicable also genetic mutations, will be recorded and stored in an electronic case report form. These parameters will be collected as part of routine daily care, patients will not undergo any additional tests for study purposes. HRCT scans will be re-analysed centrally by an experienced ILD thoracic radiologist. Mortality and lung function parameters will also be collected at 24 months, if this information is available.
- Conditions
- Pulmonary Fibrosis
- Being tested
- Electronic nose
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic noseDiagnostic test
Also called SpiroNose, eNose
First, patients will be asked to rinse their mouth thoroughly with water three times. Subsequently, exhaled breath analysis will be performed in duplicate with a 1-minute interval. An eNose measurement consists of five tidal breaths, followed by an inspiratory capacity maneuver to total lung capacity, a five second breath hold, and subsequently a slow expiration (flow <0.4L/s) to residual volume. The measurements are non-invasive and will cost approximately 5-10 minutes in total, including explanation and informed consent procedure. There are no risks associated with this study and the burden for patients is minimal.
| Study group | Role | What they receive |
|---|---|---|
| ILD patients | Patients diagnosed with one of the most prevalent fibrotic ILDs: IPF, CHP, CTD-ILD, iNSIP, IPAF, and unclassifiable ILD (defined as unclassifiable disease at the time of the first MDT). Receives: Diagnostic Test: Electronic nose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy for IPF - CHP
Accuracy for differentiating IPF from CHP
Measured: Baseline
AUC for IPF - CHP
AUC for differentiating IPF from CHP
Measured: Baseline
AUC for IPF - iNSIP
AUC for differentiating IPF from iNSIP
Measured: Baseline
Diagnostic accuracy for IPF - iNSIP
Accuracy for differentiating IPF from iNSIP
Measured: Baseline
AUC for IPF - IPAF
AUC for differentiating IPF from IPAF
Measured: Baseline
Diagnostic accuracy for IPF - IPAF
Accuracy for differentiating IPF from IPAF
Measured: Baseline
Diagnostic accuracy for IPF - CTD-ILD
Accuracy for differentiating IPF from CTD-ILD
Measured: Baseline
AUC for IPF - CTD-ILD
AUC for differentiating IPF from CTD-ILD
Measured: Baseline
Diagnostic accuracy for IPF - unclassifiable ILD
Accuracy for differentiating IPF from unclassifiable ILD
Measured: Baseline
AUC for IPF - unclassifiable ILD
AUC for differentiating IPF from unclassifiable ILD
Measured: Baseline
Diagnostic accuracy for CHP - iNSIP
Accuracy for differentiating CHP from iNSIP
Measured: Baseline
AUC for CHP - iNSIP
AUC for differentiating CHP from iNSIP
Measured: Baseline
Diagnostic accuracy for CHP - IPAF
Accuracy for differentiating CHP from IPAF
Measured: Baseline
AUC for CHP - IPAF
AUC for differentiating CHP from IPAF
Measured: Baseline
Diagnostic accuracy for CHP - CTD-ILD
Accuracy for differentiating CHP from CTD-ILD
Measured: Baseline
AUC for CHP - CTD-ILD
AUC for differentiating CHP from CTD-ILD
Measured: Baseline
Diagnostic accuracy for CHP - unclassifiable ILD
Accuracy for differentiating CHP from unclassifiable ILD
Measured: Baseline
AUC for CHP - unclassifiable ILD
AUC for differentiating CHP from unclassifiable ILD
Measured: Baseline
Diagnostic accuracy for iNSIP - IPAF
Accuracy for differentiating iNSIP from IPAF
Measured: Baseline
AUC for iNSIP - IPAF
AUC for differentiating iNSIP from IPAF
Measured: Baseline
Diagnostic accuracy for iNSIP - CTD-ILD
Accuracy for differentiating iNSIP from CTD-ILD
Measured: Baseline
AUC for iNSIP - CTD-ILD
AUC for differentiating iNSIP from CTD-ILD
Measured: Baseline
Diagnostic accuracy for iNSIP - unclassifiable ILD
Accuracy for differentiating iNSIP from unclassifiable ILD
Measured: Baseline
AUC for iNSIP - unclassifiable ILD
AUC for differentiating iNSIP from unclassifiable ILD
Measured: Baseline
Diagnostic accuracy for IPAF - CTD-ILD
Accuracy for differentiating IPAF from CTD-ILD
Measured: Baseline
AUC for IPAF - CTD-ILD
AUC for differentiating IPAF from CTD-ILD
Measured: Baseline
Diagnostic accuracy for IPAF - unclassifiable ILD
Accuracy for differentiating IPAF from unclassifiable ILD
Measured: Baseline
AUC for IPAF - unclassifiable ILD
AUC for differentiating IPAF from unclassifiable ILD
Measured: Baseline
Diagnostic accuracy for CTD-ILD - unclassifiable ILD
Accuracy for differentiating CTD-ILD from unclassifiable ILD
Measured: Baseline
AUC for CTD-ILD - unclassifiable ILD
AUC for differentiating CTD-ILD from unclassifiable ILD
Measured: Baseline
Disease progression
FVC decline in combination with worsening of respiratory symptoms (cough and/or dyspnea) and/or progressive fibrosis on CT scan
Measured: 12 months after inclusion
Disease progression
FVC decline in combination with worsening of respiratory symptoms (cough and/or dyspnea) and/or progressive fibrosis on CT scan
Measured: 24 months after inclusion
Diagnostic accuracy of disease progression
Relating disease progression (based on FVC decline, CT scan and/or symptoms) to change in eNose values
Measured: 6 months after inclusion
Diagnostic accuracy of disease progression
Relating disease progression (based on FVC decline, CT scan and/or symptoms) to change in eNose values
Measured: 12 months after inclusion
Diagnostic accuracy of disease progression
Relating disease progression (based on FVC decline, CT scan and/or symptoms) to change in eNose values
Measured: 24 months after inclusion
Worsening of respiratory symptoms (cough and/or dyspnea)
Worsening of respiratory symptoms (cough and/or dyspnea) measured on a visual analogue scale (0-10, 0 no symptoms, 10 most severe symptoms)
Measured: 12 months after inclusion
Mortality
Deceased subjects
Measured: 12 months after inclusion
Mortality
Deceased subjects
Measured: 24 months after inclusion
Therapeutic effect
Relating start of anti-fibrotic medication to change in eNose values
Measured: 6 months after start therapy
Therapeutic effect
Relating start of anti-fibrotic medication to change in eNose values
Measured: 12 months after start therapy
Secondary outcomes (12)
L-PF evaluation
Relating Longitudinal changes in score of L-PF questionnaire to eNose values
Measured: 6 months after inclusion
L-PF evaluation
Relating Longitudinal changes in score of L-PF questionnaire to lung function values
Measured: 6 months after inclusion
L-PF evaluation
Relating Longitudinal changes in score of L-PF questionnaire to eNose values
Measured: 12 months after inclusion
L-PF evaluation
Relating Longitudinal changes in score of L-PF questionnaire to lung function values
Measured: 12 months after inclusion
L-PF evaluation
Relating Longitudinal changes in score of L-PF questionnaire to eNose values
Measured: 24 months after inclusion
L-PF evaluation
Relating Longitudinal changes in score of L-PF questionnaire to lung function values
Measured: 24 months after inclusion
GRoC evaluation
Relating Longitudinal changes in score of Global Rating of Change Scale to eNose values
Measured: 6 months after inclusion
GRoC evaluation
Relating Longitudinal changes in score of Global Rating of Change Scale to lung function values
Measured: 6 months after inclusion
GRoC evaluation
Relating Longitudinal changes in score of Global Rating of Change Scale to eNose values
Measured: 12 months after inclusion
GRoC evaluation
Relating Longitudinal changes in score of Global Rating of Change Scale to lung function values
Measured: 12 months after inclusion
GRoC evaluation
Relating Longitudinal changes in score of Global Rating of Change Scale to eNose values
Measured: 24 months after inclusion
GRoC evaluation
Relating Longitudinal changes in score of Global Rating of Change Scale to lung function values
Measured: 24 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Nov 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlies Wijsenbeek, Erasmus Medical Center
- Investigators
- Marlies S Wijsenbeek, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680832
- Sponsor's protocol ID
- MEC-2020-0655
- Acronym
- ILDnose
- Status last verified
- Jan 2025
- First submitted
- 11 Dec 2020
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Analysis Using eNose Technology as a Biomarker for Diagnosis and Disease Progression in Fibrotic Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT04680832
- Acronym / sponsor ID
- ILDnose / MEC-2020-0655
- Conditions
- Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Dec 2020 (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.
The ILDnose study a multinational, multicenter, prospective, longitudinal study in outpatients with pulmonary fibrosis. The aim is to assess the accuracy of eNose technology as diagnostic tool for diagnosis and differentiation between the most prevalent fibrotic interstitial lung diseases. The value of eNose as biomarker for disease progression and response to treatment is also assessed. Besides, validity of several questionnaires for pulmonary fibrosis is investigated.
Detailed description
Patients will be included in the study after signing written informed consent. eNose measurements will take place before or after a routine outpatient clinic visit at the same location as the regular visit, ensuring minimal inconvenience for patients. First, patients will be asked to rinse their mouth thoroughly with water three times. Subsequently, exhaled breath analysis will be performed in duplicate with a 1-minute interval. An eNose measurement consists of five tidal breaths, followed by an inspiratory capacity maneuver to total lung capacity, a five second breath hold, and subsequently a slow expiration (flow <0.4L/s) to residual volume. The measurements are non-invasive and will cost approximately 5-10 minutes in total, including explanation and informed consent procedure. There are no risks associated with this study and the burden for patients is minimal.
After the measurement, patients will complete a short survey about questions relevant for the data analysis (food intake in the last two hours, smoking history, medication use, comorbidities, and symptoms of respiratory infection). In addition, patients will complete the L-PF questionnaire and the Global Rating of Change scale (GRoC). The L-PF questionnaire consists of 21 questions on a 5-point Likert scale about the impact of pulmonary fibrosis on quality of life, and takes about 3 minutes to complete. The GRoC consists of one question on a scale from -7 to 7: were there any changes in your quality of life since your last visit? Symptoms (cough and dyspnea) will be scored on a 10 cm VAS scale from -5 to 5.
Next to eNose measurements, demographic data and physiological parameters of patients will be collected from the medical records at baseline, month 6, and month 12. Parameters such as age, gender, diagnosis, time since diagnosis, comorbidities, medication, pulmonary function (forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO)), laboratory parameters (i.e. auto-immune antibodies), HRCT pattern, BAL results and if applicable also genetic mutations, will be recorded and stored in an electronic case report form. These parameters will be collected as part of routine daily care, patients will not undergo any additional tests for study purposes. HRCT scans will be re-analysed centrally by an experienced ILD thoracic radiologist. Mortality and lung function parameters will also be collected at 24 months, if this information is available.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ILD patients | – | Diagnostic Test: Electronic nosePatients diagnosed with one of the most prevalent fibrotic ILDs: IPF, CHP, CTD-ILD, iNSIP, IPAF, and unclassifiable ILD (defined as unclassifiable disease at the time of the first MDT). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with ILD
Key inclusion criteria (1 listed)
- Patients with a diagnosis of fibrotic ILD, as discussed in a multidisciplinary team meeting (50% incident patients and 50% prevalent patients). Patients are classified as 'incident' if they received a diagnosed in a multidisciplinary team meeting within the past six months. Patients will be required to have fibrosis on a HRCT scan <1 year before enrollment in the study defined as reticular abnormality with traction bronchiectasis, with or without honeycombing, as determined by a radiologist. No minimum extent of fibrosis will be required.
Key exclusion criteria (2 listed)
- Alcohol consumption ≤ 12 hours before the measurement
- Physically not able to perform eNose measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic noseAlso: SpiroNose, eNoseFirst, patients will be asked to rinse their mouth thoroughly with water three times. Subsequently, exhaled breath analysis will be performed in duplicate with a 1-minute interval. An eNose measurement consists of five tidal breaths, followed by an inspiratory capacity maneuver to total lung capacity, a five second breath hold, and subsequently a slow expiration (flow <0.4L/s) to residual volume. The measurements are non-invasive and will cost approximately 5-10 minutes in total, including explanation and informed consent procedure. There are no risks associated with this study and the burden for patients is minimal. | Diagnostic test | ILD patients |
Primary outcome
Diagnostic accuracy for IPF - CHP
Time frame: Baseline
Accuracy for differentiating IPF from CHP
AUC for IPF - CHP
Time frame: Baseline
AUC for differentiating IPF from CHP
AUC for IPF - iNSIP
Time frame: Baseline
AUC for differentiating IPF from iNSIP
Diagnostic accuracy for IPF - iNSIP
Time frame: Baseline
Accuracy for differentiating IPF from iNSIP
AUC for IPF - IPAF
Time frame: Baseline
AUC for differentiating IPF from IPAF
Diagnostic accuracy for IPF - IPAF
Time frame: Baseline
Accuracy for differentiating IPF from IPAF
Diagnostic accuracy for IPF - CTD-ILD
Time frame: Baseline
Accuracy for differentiating IPF from CTD-ILD
AUC for IPF - CTD-ILD
Time frame: Baseline
AUC for differentiating IPF from CTD-ILD
Diagnostic accuracy for IPF - unclassifiable ILD
Time frame: Baseline
Accuracy for differentiating IPF from unclassifiable ILD
AUC for IPF - unclassifiable ILD
Time frame: Baseline
AUC for differentiating IPF from unclassifiable ILD
Diagnostic accuracy for CHP - iNSIP
Time frame: Baseline
Accuracy for differentiating CHP from iNSIP
AUC for CHP - iNSIP
Time frame: Baseline
AUC for differentiating CHP from iNSIP
Diagnostic accuracy for CHP - IPAF
Time frame: Baseline
Accuracy for differentiating CHP from IPAF
AUC for CHP - IPAF
Time frame: Baseline
AUC for differentiating CHP from IPAF
Diagnostic accuracy for CHP - CTD-ILD
Time frame: Baseline
Accuracy for differentiating CHP from CTD-ILD
AUC for CHP - CTD-ILD
Time frame: Baseline
AUC for differentiating CHP from CTD-ILD
Diagnostic accuracy for CHP - unclassifiable ILD
Time frame: Baseline
Accuracy for differentiating CHP from unclassifiable ILD
AUC for CHP - unclassifiable ILD
Time frame: Baseline
AUC for differentiating CHP from unclassifiable ILD
Diagnostic accuracy for iNSIP - IPAF
Time frame: Baseline
Accuracy for differentiating iNSIP from IPAF
AUC for iNSIP - IPAF
Time frame: Baseline
AUC for differentiating iNSIP from IPAF
Diagnostic accuracy for iNSIP - CTD-ILD
Time frame: Baseline
Accuracy for differentiating iNSIP from CTD-ILD
AUC for iNSIP - CTD-ILD
Time frame: Baseline
AUC for differentiating iNSIP from CTD-ILD
Diagnostic accuracy for iNSIP - unclassifiable ILD
Time frame: Baseline
Accuracy for differentiating iNSIP from unclassifiable ILD
AUC for iNSIP - unclassifiable ILD
Time frame: Baseline
AUC for differentiating iNSIP from unclassifiable ILD
Diagnostic accuracy for IPAF - CTD-ILD
Time frame: Baseline
Accuracy for differentiating IPAF from CTD-ILD
AUC for IPAF - CTD-ILD
Time frame: Baseline
AUC for differentiating IPAF from CTD-ILD
Diagnostic accuracy for IPAF - unclassifiable ILD
Time frame: Baseline
Accuracy for differentiating IPAF from unclassifiable ILD
AUC for IPAF - unclassifiable ILD
Time frame: Baseline
AUC for differentiating IPAF from unclassifiable ILD
Diagnostic accuracy for CTD-ILD - unclassifiable ILD
Time frame: Baseline
Accuracy for differentiating CTD-ILD from unclassifiable ILD
AUC for CTD-ILD - unclassifiable ILD
Time frame: Baseline
AUC for differentiating CTD-ILD from unclassifiable ILD
Disease progression
Time frame: 12 months after inclusion
FVC decline in combination with worsening of respiratory symptoms (cough and/or dyspnea) and/or progressive fibrosis on CT scan
Disease progression
Time frame: 24 months after inclusion
FVC decline in combination with worsening of respiratory symptoms (cough and/or dyspnea) and/or progressive fibrosis on CT scan
Diagnostic accuracy of disease progression
Time frame: 6 months after inclusion
Relating disease progression (based on FVC decline, CT scan and/or symptoms) to change in eNose values
Diagnostic accuracy of disease progression
Time frame: 12 months after inclusion
Relating disease progression (based on FVC decline, CT scan and/or symptoms) to change in eNose values
Diagnostic accuracy of disease progression
Time frame: 24 months after inclusion
Relating disease progression (based on FVC decline, CT scan and/or symptoms) to change in eNose values
Worsening of respiratory symptoms (cough and/or dyspnea)
Time frame: 12 months after inclusion
Worsening of respiratory symptoms (cough and/or dyspnea) measured on a visual analogue scale (0-10, 0 no symptoms, 10 most severe symptoms)
Mortality
Time frame: 12 months after inclusion
Deceased subjects
Mortality
Time frame: 24 months after inclusion
Deceased subjects
Therapeutic effect
Time frame: 6 months after start therapy
Relating start of anti-fibrotic medication to change in eNose values
Therapeutic effect
Time frame: 12 months after start therapy
Relating start of anti-fibrotic medication to change in eNose values
12 secondary outcomes
L-PF evaluation
Time frame: 6 months after inclusion
L-PF evaluation
Time frame: 6 months after inclusion
L-PF evaluation
Time frame: 12 months after inclusion
L-PF evaluation
Time frame: 12 months after inclusion
L-PF evaluation
Time frame: 24 months after inclusion
L-PF evaluation
Time frame: 24 months after inclusion
GRoC evaluation
Time frame: 6 months after inclusion
GRoC evaluation
Time frame: 6 months after inclusion
GRoC evaluation
Time frame: 12 months after inclusion
GRoC evaluation
Time frame: 12 months after inclusion
GRoC evaluation
Time frame: 24 months after inclusion
GRoC evaluation
Time frame: 24 months after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Marlies S Wijsenbeek, MD PhD principal investigator
Erasmus Medical Center
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Fibrosis, run by Erasmus Medical Center at 5 sites in 5 countries.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, France, Germany, Netherlands, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Diagnostic accuracy for IPF - CHP (time frame: Baseline). The study lists 40 primary outcomes in all. 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 18 Jun 2025.