Lung DiseasesPO-PIDNCT04195789
Assessment of Interstitial Lung Disease in Rheumatoid Arthritis by Lung Ultrasound
An observational study of Lung Diseases and Lung Diseases, Interstitial, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The high resolution chest scan is the gold standard for the screening of interstitial lung disease, but this remains an onerous examination, and irradiating. Ultrasound could be used to detect these disorders with a very good sensitivity and specificity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Lung Diseases, Interstitial, Rheumatoid Arthritis
- What is being tested?
- Lung sonography
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 4 Aug 2020to 4 Jun 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed for a rheumatoid arthritis
Who may be able to join
- Men and women over the age of 18
- With rheumatoid arthritis meeting the criteria ACR (American College of Rheumatology)/ EULAR (EUropean League Against Rheumatism) 2010
- Never received any biotherapy or targeted therapy
- Having an indication of introduction of biotherapy or therapy targeted (JAK inhibitors) (JAK : Janus kinase)
Who cannot join
- Refusal to participate in the study
- Known pulmonary disease that can alter lung interstitium: cardiac decompensation, COPD (chronic obstructive pulmonary disease), thoracic surgery, infection pulmonary
- Patient with respiratory functional signs suggestive of PID (Diffuse interstitial lung disease)
- Patient with signs of cardiac decompensation
- Patient with pulmonary auscultation suggestive of PID
- Pregnant or lactating woman
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- Psychiatric pathology seriously hindering understanding
- Difficulty understanding oral French
- Person deprived of liberty or under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Rhumatologie. Centre hospitalier Lyon Sud. 69310
Pierre-Bénite, 69310
About this study
The high resolution chest scan is the gold standard for the screening of interstitial lung disease, but this remains an onerous examination, and irradiating.
Ultrasound could be used to detect these disorders with a very good sensitivity and specificity. This exam offers the advantage of being non radiating, inexpensive, and accessible to the rheumatologist who already uses it in their daily practice.
Read more
The investigators want to assess the lung ultrasound performance compared with the gold standard.
Patients will be included during a regular follow-up consultation with their referent rheumatologist. If there is an indication of first line biotherapy or targeted therapy the doctor will propose to the patient to participate in the study, give him the information leaflet, collect orally non-opposition, and will complete a survey for evaluation of the general health and potential risk factors for interstitial lung.
- Being tested
- Lung sonography
- Medical subject headings
- Lung Diseases, Lung Diseases, Interstitial, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung sonographyOther
Realization of a lung sonography with scoring of the number of B-lines exploring 14 intercostal spaces.
Duration of the exam : twenty minutes. Recording for a second analysis by another lung specialist.
| Study group | Role | What they receive |
|---|---|---|
| Sample population | Patients with Rheumatoid Arthritis consultant for the start of a biotherapy or targeted therapy agreeing to participate. Receives: Other: Lung sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensibility and specificity of the lung sonography for interstitial lung disease screening in rheumatoid arthritis patients.
To estimate the sensitivity and specificity of pulmonary ultrasound compared to CT scans in patients with rheumatoid arthritis consulting at the Lyon South Hospital Centre or the Edouard Herriot Hospital for the start-up of biotherapy or targeted therapy. (CT : computerized tomography)
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start4 Aug 2020
- Primary completion4 May 2024
- Study completion4 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195789
- Sponsor's protocol ID
- 69HCL19_0859
- Acronym
- PO-PID
- Status last verified
- Oct 2024
- First submitted
- 10 Dec 2019
- Last updated
- 10 Oct 2024
- 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 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Interstitial Lung Disease in Rheumatoid Arthritis by Lung Ultrasound
- ClinicalTrials.gov ID
- NCT04195789
- Acronym / sponsor ID
- PO-PID / 69HCL19_0859
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 4 May 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 12 Dec 2019 (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 high resolution chest scan is the gold standard for the screening of interstitial lung disease, but this remains an onerous examination, and irradiating.
Ultrasound could be used to detect these disorders with a very good sensitivity and specificity. This exam offers the advantage of being non radiating, inexpensive, and accessible to the rheumatologist who already uses it in their daily practice.
The investigators want to assess the lung ultrasound performance compared with the gold standard.
Patients will be included during a regular follow-up consultation with their referent rheumatologist. If there is an indication of first line biotherapy or targeted therapy the doctor will propose to the patient to participate in the study, give him the information leaflet, collect orally non-opposition, and will complete a survey for evaluation of the general health and potential risk factors for interstitial lung.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample population | – | Other: Lung sonographyPatients with Rheumatoid Arthritis consultant for the start of a biotherapy or targeted therapy agreeing to participate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed for a rheumatoid arthritis
Key inclusion criteria (4 listed)
- Men and women over the age of 18
- With rheumatoid arthritis meeting the criteria ACR (American College of Rheumatology)/ EULAR (EUropean League Against Rheumatism) 2010
- Never received any biotherapy or targeted therapy
- Having an indication of introduction of biotherapy or therapy targeted (JAK inhibitors) (JAK : Janus kinase)
Key exclusion criteria (9 listed)
- Refusal to participate in the study
- Known pulmonary disease that can alter lung interstitium: cardiac decompensation, COPD (chronic obstructive pulmonary disease), thoracic surgery, infection pulmonary
- Patient with respiratory functional signs suggestive of PID (Diffuse interstitial lung disease)
- Patient with signs of cardiac decompensation
- Patient with pulmonary auscultation suggestive of PID
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 |
|---|---|---|
| Lung sonographyRealization of a lung sonography with scoring of the number of B-lines exploring 14 intercostal spaces. Duration of the exam : twenty minutes. Recording for a second analysis by another lung specialist. | Other | Sample population |
Primary outcome
Sensibility and specificity of the lung sonography for interstitial lung disease screening in rheumatoid arthritis patients.
Time frame: Month 12
To estimate the sensitivity and specificity of pulmonary ultrasound compared to CT scans in patients with rheumatoid arthritis consulting at the Lyon South Hospital Centre or the Edouard Herriot Hospital for the start-up of biotherapy or targeted therapy. (CT : computerized tomography)
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 10 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Diseases and Lung Diseases, Interstitial, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 9 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 10 Oct 2024. 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 France. 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?
Sensibility and specificity of the lung sonography for interstitial lung disease screening in rheumatoid arthritis patients. (time frame: Month 12). 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 10 Oct 2024.