RecruitingRecruiting
dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound
NCT06235645 · University Hospital, Tours
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
Patients with RA and who have risk factors for RA-ILD are regularly reassessed in a rheumatology day hospital.
As part of their routine follow-up, and given the absence of recommendations on screening for RA-ILD in this population, chest CT and PFT (pulmonary function tests) are regularly performed at the request of the rheumatologist.
Therefore, all patients meeting the inclusion criteria and having undergone chest CT and PFT in the 6 months preceding or following their rheumatology reassessment will be offered participation in the study.
Participation in the study does not alter the patient's usual follow-up.
Objective of the study: evaluate the sensitivity and specificity of thoracic ultrasound compare to the chest CT in patients with risk factors of developing RA-ILD.
Design: This is a non-interventional, prospective, single-center, multidisciplinary study.
Eligibility criteria
Inclusion Criteria:
* Adult patient (age \> 18 years) followed at CHU of Tours
* Diagnosis of rheumatoid arthritis validated according to ACR 2010 criteria, EULAR classification, regardless of time since diagnosis
* Patient who has had or will have a thoracic CT scan and PFT performed as part of routine care in the 6 months preceding or following inclusion
* Patient with at least two risk factors for developing RA-ILD among :
* Male sex or
* Active or former smoker assessed at 20 pack-year or
* Age \> 60 years or
* Levels of RF≥3N (rheumatoid factor) and/or anti-CCP≥3N (antibodies against cyclic citrullinated peptides) at diagnosis or at any time during the course of the disease or
* High RA activity score (DAS28\>3.2)
Exclusion Criteria:
* Diagnosis of congenital lung disease
* Diagnosis of another autoimmune pathology associated with RA (overlap syndrome) linked to the development of ILD (interstitial lung disease) (systemic sclerosis, myositis, dermatomyositis, mixed connectivitis, systemic lupus erythematosus or other ANCA vasculitis, with the exception of secondary Gougerot-Sjögren's syndromes).
* Current or operated lung cancer
* Thoracic irradiation
* Thoracic transplant patients
* Previous invasive thoracic procedures
* Pathologies responsible for pleural thickening (silicosis, asbestosis, known pleural plaque, pleural sequelae of tuberculosis)
* Pregnant or breast-feeding women
* Patient under legal protection (guardianship, curatorship or safeguard of justice)
* Patient who has objected to data processing
* Parenchymal infection current or less than one month old prior to LUS examination
* Liquid or gaseous pleural effusion
Study design
Enrollment target: 280 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-11-18
Estimated completion: 2027-03
Last updated: 2026-04-30
Interventions
Diagnostic Test: Lung ultrasound (LUS)
Primary outcomes
- • Determination sensitivity and specificity of thoracic ultrasound (2 years)
Sponsor
University Hospital, Tours · other
Contacts & investigators
ContactSylvie LEGUE · contact · s.legue@chu-tours.fr · 0247479835
ContactAriane MERLIN-DOMONT · contact · x.ariane.md@gmail.com
InvestigatorSylvie LEGUE · principal_investigator, University Hospital, Tours
All locations (1)
university hospital ToursRecruiting
Tours, France