Clinical Relevance of Thoracic Echography for the Early Diagnosis of Interstitial Lung Disease in Systemic Scleroderma - Pilot Study

NCT ID: NCT04725786

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-17
• Study Completion Date: 2022-06-08

Brief 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. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Case group

The intervention of the research corresponds to the realization of a thoracic echography.

Group Type: EXPERIMENTAL

thoracic echography

Intervention Type: OTHER

The research intervention corresponds to the performance of a thoracic echography to diagnose an incipient pulmonary interstitial syndrome.

Interventions

thoracic echography

The research intervention corresponds to the performance of a thoracic echography to diagnose an incipient pulmonary interstitial syndrome.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHRU Tours

Tours, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 38792426 (View on PubMed)

Other Identifiers

2020-A03249-30

Identifier Type: REGISTRY

Identifier Source: secondary_id

DR20098

Identifier Type: -

Identifier Source: org_study_id