Systemic SclerosisPRECOSSNCT04725786
Clinical Relevance of Thoracic Echography for the Early Diagnosis of Interstitial Lung Disease in Systemic Scleroderma - Pilot Study
A study testing thoracic echography in people with Systemic Sclerosis, run by University Hospital, Tours at 1 site in France.
Trial summary
Diffuse interstitial lung disease (PID) is the leading cause of death in systemic scleroderma (SSc). Major progress has recently been made in its therapeutic management. Early diagnosis is essential to optimize this management. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- thoracic echography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2021to 8 Jun 2022
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Diagnosis of systemic scleroderma according to EULAR/ACR 2013 criteria
- Absence of diffuse interstitial lung disease proven by scanner on the day of inclusion
- Forced vital capacity ≥ 80% of the value predicted on the last respiratory function test performed.
- Carbon monoxide diffusion capacity corrected for hemoglobinemia ≥ 70% of the value predicted on the last respiratory function test performed.
- Patient capable of performing functional exploration during the year
- Affiliation to a social security system
- Patient who has given free and informed consent
Who cannot join
- Any other connectivity associated to systemic sleroderma
- Any chronic pathologies, co-morbidities, history judged by the investigator as being likely to lead to complications for the patient and/or which may impact the results of functional exploration during exercise.
- All known fibrotic and/or obstructive respiratory pathologies.
- Presence of echocardiographic signs of pulmonary arterial hypertension according to 2015 criteria
- Diagnosis of left heart disease
- Cumulative smoking > 10 packs.years
Show all 12Show fewer
- Infectious pneumonia within 90 days prior to inclusion
- Acute respiratory illness requiring hospitalization within one year prior to inclusion
- Pregnant or breastfeeding woman
- Refusal to participate in the study
- Refusal to use the data
- Adults under legal protection (temporary protection measure, curatorship, guardianship)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pertinence Clinique de l'échographie Thoracique Pour le Diagnostic précoce de la Pneumopathie Interstitielle Diffuse de la sclérodermie systémique - Etude Pilote
Diffuse interstitial lung disease (PID) is the leading cause of death in systemic scleroderma (SSc). Major progress has recently been made in its therapeutic management. Early diagnosis is essential to optimize this management. Current diagnostic techniques are based on high-resolution computed tomography on the thorax (HRCT) and pulmonary functional tests (PFT). However, these explorations have their limitations. Thus, there is a need for new techniques for a very early diagnosis of PID-SSc.
Thoracic ultrasound (TUS) is an innovative, easily accessible, non-irradiating, inexpensive and painless tool. It is an emerging technique for the diagnosis of PID and has already proven its sensitivity for the detection of interstitial damage, as defined by HRCT.
The main objective of the PRECOSS study is to describe the prevalence of an ultrasound interstitial syndrome in patients with SSc, free of PID-SSc (defined by the Goh criteria) detectable by HRCT.
- Conditions
- Systemic Sclerosis
- Being tested
- thoracic echography
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic echographyOther
The research intervention corresponds to the performance of a thoracic echography to diagnose an incipient pulmonary interstitial syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Experimental | The intervention of the research corresponds to the realization of a thoracic echography. Receives: Other: thoracic echography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of interstitial syndrome on echography
Interstitial syndrome is defined by the total number of B lines is greather than or equal to 10 and/or the average thickness of the pleural line is greater than 3 mm on at least one test site and/or the irregularity score of the pleural line is greater than 16%
Measured: At baseline
Secondary outcomes (15)
Ventilatory mechanics
Measured by spirometry
Measured: At Baseline
Ventilatory mechanics
Measured by plethysmography
Measured: At Baseline
Ventilatory mechanics
Measured by impulse oscillometry
Measured: At Baseline
Ventilatory mechanics
Measured by cardiopulmonary exercise testing
Measured: At Baseline
Pulmonary gas exchange
Measured by cardiopulmonary exercise testing
Measured: At Baseline
Pulmonary gas exchange
Measured by Diffusing capacity for carbon monoxide
Measured: At baseline
Pulmonary gas exchange
Measured by 6-minute walk test
Measured: At baseline
Exercise capacity
Measured by cardiopulmonary exercise testing
Measured: At baseline
Circulatory response
Measured by cardiopulmonary exercise testing
Measured: At baseline
Dyspnoea
Measured by cardiopulmonary exercise testing
Measured: At baseline
Dyspnoea
Assessed by Dyspnea12
Measured: At baseline
Dyspnoea
Assessed by Modified Medical Research Council (mMRC) Scale
Measured: At baseline
Assessment of Quality of life
Assessed by Cochin 17-item Scleroderma Functional Scale
Measured: At baseline
Assessment of Quality of life
Assessed by Saint George's Respiratory Questionnaire (SGRQ)
Measured: At baseline
Cough
Evaluation by Leicester Cough Questionnaire - French translation
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start17 Mar 2021
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725786
- Sponsor's protocol ID
- DR20098
- Other IDs
- 2020-A03249-30
- Acronym
- PRECOSS
- Status last verified
- Jun 2022
- First submitted
- 13 Jan 2021
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mercier C, Thoreau B, Flament T, Legue S, Pearson A, Jobard S, Marchand-Adam S, Plantier L, Diot E. High Prevalence of the Lung Ultrasound Interstitial Syndrome in Systemic Sclerosis Patients with Normal HRCT and Lung Function-A Pilot Study. J Clin Med. 2024 May 14;13(10):2885. doi: 10.3390/jcm13102885.
PubMed 38792426
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pertinence Clinique de l'échographie Thoracique Pour le Diagnostic précoce de la Pneumopathie Interstitielle Diffuse de la sclérodermie systémique - Etude Pilote
- ClinicalTrials.gov ID
- NCT04725786
- Acronym / sponsor ID
- PRECOSS / DR20098
- Conditions
- Systemic Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 27 Jan 2021 (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.
Diffuse interstitial lung disease (PID) is the leading cause of death in systemic scleroderma (SSc). Major progress has recently been made in its therapeutic management. Early diagnosis is essential to optimize this management. Current diagnostic techniques are based on high-resolution computed tomography on the thorax (HRCT) and pulmonary functional tests (PFT). However, these explorations have their limitations. Thus, there is a need for new techniques for a very early diagnosis of PID-SSc.
Thoracic ultrasound (TUS) is an innovative, easily accessible, non-irradiating, inexpensive and painless tool. It is an emerging technique for the diagnosis of PID and has already proven its sensitivity for the detection of interstitial damage, as defined by HRCT.
The main objective of the PRECOSS study is to describe the prevalence of an ultrasound interstitial syndrome in patients with SSc, free of PID-SSc (defined by the Goh criteria) detectable by HRCT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case group | Experimental | Other: thoracic echographyThe intervention of the research corresponds to the realization of a thoracic echography. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years old
- Diagnosis of systemic scleroderma according to EULAR/ACR 2013 criteria
- Absence of diffuse interstitial lung disease proven by scanner on the day of inclusion
- Forced vital capacity ≥ 80% of the value predicted on the last respiratory function test performed.
- Carbon monoxide diffusion capacity corrected for hemoglobinemia ≥ 70% of the value predicted on the last respiratory function test performed.
Key exclusion criteria (12 listed)
- Any other connectivity associated to systemic sleroderma
- Any chronic pathologies, co-morbidities, history judged by the investigator as being likely to lead to complications for the patient and/or which may impact the results of functional exploration during exercise.
- All known fibrotic and/or obstructive respiratory pathologies.
- Presence of echocardiographic signs of pulmonary arterial hypertension according to 2015 criteria
- Diagnosis of left heart disease
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 |
|---|---|---|
| thoracic echographyThe research intervention corresponds to the performance of a thoracic echography to diagnose an incipient pulmonary interstitial syndrome. | Other | Case group |
Primary outcome
Presence of interstitial syndrome on echography
Time frame: At baseline
Interstitial syndrome is defined by the total number of B lines is greather than or equal to 10 and/or the average thickness of the pleural line is greater than 3 mm on at least one test site and/or the irregularity score of the pleural line is greater than 16%
15 secondary outcomes
Ventilatory mechanics
Time frame: At Baseline
Ventilatory mechanics
Time frame: At Baseline
Ventilatory mechanics
Time frame: At Baseline
Ventilatory mechanics
Time frame: At Baseline
Pulmonary gas exchange
Time frame: At Baseline
Pulmonary gas exchange
Time frame: At baseline
Pulmonary gas exchange
Time frame: At baseline
Exercise capacity
Time frame: At baseline
Circulatory response
Time frame: At baseline
Dyspnoea
Time frame: At baseline
Dyspnoea
Time frame: At baseline
Dyspnoea
Time frame: At baseline
Assessment of Quality of life
Time frame: At baseline
Assessment of Quality of life
Time frame: At baseline
Cough
Time frame: At baseline
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 22 Dec 2025.
- Results publication: PubMed 38792426Mercier C, Thoreau B, Flament T, Legue S, Pearson A, Jobard S, Marchand-Adam S, Plantier L, Diot E. High Prevalence of the Lung Ultrasound Interstitial Syndrome in Systemic Sclerosis Patients with Normal HRCT and Lung Function-A Pilot Study. J Clin Med. 2024 May 14;13(10):2885. doi: 10.3390/jcm13102885.
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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?
A study testing thoracic echography in people with Systemic Sclerosis, run by University Hospital, Tours 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 8 inclusion and 12 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 22 Dec 2025. 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?
Presence of interstitial syndrome on echography (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04725786, which also lists 1 linked publication.
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 22 Dec 2025.