Early detection of progressive lung fibrosis in connective tissue diseases
Early Recognition of Progressive Lung Fibrosis in Systemic Rheumatic Diseases: a Characterization of the Pulmonary Environment Through Extracellular Vesicles, Advanced and Functional Imaging
This project will test whether blood extracellular vesicle biomarkers combined with AI-analyzed HRCT scans can detect and predict progressive interstitial lung disease in adults with connective tissue diseases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | rituximab, prednisone |
| Locations | 1 site (Roma) |
| Trial ID | NCT07541638 on ClinicalTrials.gov |
What this trial studies
Adults aged 18–75 with systemic connective tissue diseases who are at high risk for ILD and have HRCT evidence of lung involvement will be enrolled. Researchers will isolate extracellular vesicles from serum and perform proteomic and transcriptomic analyses to identify molecular signatures linked to ILD. Those molecular data will be integrated with artificial-intelligence analysis of high-resolution CT scans to derive combined imaging–molecular biomarkers of current disease and risk of progression. No investigational drugs or devices are administered; the protocol involves blood sampling and imaging analysis only.
Who should consider this trial
Good fit: Adults 18–75 with a confirmed diagnosis of SSc, RA, SS, IIM, or UCTD, a high-risk autoantibody profile as specified in the protocol, and HRCT evidence of ILD are the ideal candidates.
Not a fit: People without a connective tissue disease diagnosis, without ILD on HRCT, or lacking the specified high-risk autoantibodies are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enable earlier and more accurate detection of ILD progression in CTD patients, allowing earlier targeted treatment to reduce disability and death.
How similar studies have performed: Some promising studies have reported EV biomarker signals in idiopathic pulmonary fibrosis and AI tools have been applied to HRCT in ILD, but combining EV omics with AI imaging specifically in CTD-ILD is novel and largely untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Roma
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Silvia Laura Bosello — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Silvia Laura Bosello, MD PhD
- Email: silvialaura.bosello@policlinicogemelli.it
- Phone: +390630159650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.