Condition: Connective Tissue Diseases · Interstitial Lung Disease · Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Connective tissue diseases (CTDs) cover a broad range of systemic rheumatic disorders characterized by abnormal immune activation, chronic inflammatory response, and fibrosis of internal organs. The most prevalent is interstitial lung disease (ILD), a severe pulmonary complication seen in 10 to 50% of CTDs and a major determinant of disability and death. Prevalence and clinical course of CTD-ILDs vary widely and seem to be independent of treatment. Current screening and prognosis prediction strategies based on clinical variables and auto-antibodies are inadequate, and disease biomarkers are lacking. The research project aims to identify biomarkers of ILD involvement in CTD patients by characterizing the proteome and transcriptome of extracellular vesicles (EVs) isolated from serum. This will be integrated with high-resolution computed tomography (HRCT) using artificial intelligence (AI)-based imaging assessment. These novel biomarkers are expected to address some current limitations of standard laboratory biomarkers and conventional HRCT imaging. The investigator will involve a total of 200 CTD patients divided into two equal groups: those with ILD and those without. Serum EVs will be extracted from patient sera and characterized based on proteome and transcriptome content using mass spectrometry analysis and next-generation RNA-sequencing. The investigator will compare CTD patients with and without ILD, and progressive and non-progressive ILD patients according to OMERACT (…
This description comes directly from the study's public registry record.
Silvia Laura Bosello, MD PhD · +390630159650 · silvialaura.bosello@policlinicogemelli.it
Giulia Wlderk, Biologist · +390630159650 · giulia.wlderk@policlinicogemelli.it
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| Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma, Italy | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07541638