Early detection of progressive lung fibrosis in connective tissue diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using capillaroscopy to help diagnose diffuse interstitial pneumonias

  We will test whether adding nailfold capillaroscopy to standard care helps doctors diagnose connective-tissue–related interstitial lung disease faster in adults newly diagnosed with pulmonary interstitial disease.

  Recruiting University Hospital, Bordeaux · Bordeaux · NCT07283081

• Understanding genetic and environmental factors in pulmonary fibrosis

  This study looks at how genes and environmental factors affect pulmonary fibrosis to help understand the disease better for people who have it.

  Recruiting Royal College of Surgeons, Ireland · Dublin · NCT06702228

• Using stem cells to treat lung disease in patients with connective tissue disorders

  This study is testing if a new treatment using stem cells can help improve lung function in patients with lung disease caused by connective tissue disorders.

  Recruiting Phase 1/2 China Medical University Hospital · Taichung · NCT06574581

• Registry of patients with connective tissue diseases and lung issues

  This study is collecting health information from patients with connective tissue diseases to see how often they develop lung problems and to understand their treatment over time.

  Recruiting Medical University Innsbruck · Innsbruck · NCT04095351

• Telitacicept for primary Sjögren’s with interstitial lung disease

  This study tests whether Telitacicept helps people with primary Sjögren’s syndrome and interstitial lung disease compared with standard immunosuppressants.

  Recruiting Peking University People's Hospital · Beijing · NCT07843381

• Inhaled mosliciguat for pulmonary hypertension in interstitial lung disease (PH-ILD) patients

  This study tests inhaled mosliciguat versus placebo in people with PH-ILD to see if it helps with their condition.

  Recruiting at 3 sites Phase 3 Pulmovant, Inc. · Kissimmee, Florida and 2 other locations · NCT07816185

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.