RecruitingNANCT07541638

Early Recognition of Progressive Lung Fibrosis in Systemic Rheumatic Diseases: a Characterization of the Pulmonary Environment Through Extracellular Vesicles, Advanced and Functional Imaging

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Trial Details

ConditionConnective Tissue Diseases, Interstitial Lung Disease
InterventionNo experimental intervention (medication or device)
PhaseNA
StatusRecruiting
Participants200
Est. Completion30 June 2026
Last Updated21 Apr 2026

Primary Outcome

Serum EV characteristics according to ILD presence

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: * Female and male aged between 18 and 75 years. * Signature of informed consent * A clinical diagnosis of SSc, RA, SS, IIM, or UCTD that must adhere to internationally accepted classification criteria \[Aletha 2010, Van Der Hoogen 2013, Lundberg 2017, Shiboski 2016, Bottai 2017, Antunes 2019\]. * A high risk of ILD based on autoantibody profile, specifically: anti-Scl70+ or anti-RNAPIII+ for SSc, anti-CCP+ and/or RF+ for RA, anti-RoSSA+ and anti-LaSSB+ for primary SS, anti-synthetase+ for IIM. For UCTD patients, the enrollment criteria will be adapted to match those of Interstitial Pneumonia with Autoimmune Features (IPAF) \[Fernandes 2019\], with patients exhibiting one clinical feature of CTD and one serological domain criterion (e.g., ANA positive with nucleolar pattern, RF and anti-CCP positivity, anti-RoSSA and anti-LaSSB positivity, anti-Scl70 positivity) while not meeting the classification criteria for any other CTD. * Evidence of ILD based on an HRCT documenting the presence of interstitial changes involving at least 10% of the parenchyma within the previous 6 weeks. An HRCT scan completely negative for ILD changes performed up to 6 weeks before enrollment will be evaluated for the group of CTD patients without ILD. * Either naive to immunosuppressants or having been on a stable immunosuppressive regimen for the three months preceding blood collection for EV characterization. Treatment with rituximab must be not administered in the previous 24 weeks. Exclusion Criteria: * Current treatment with corticosteroids \>10 mg of prednisone. * Poor peripheral venus access that would interfere with blood sampling

Trial Sites

Countries

Italy
View Registry Entry

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