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NCT06932497

Gemelli Longitudinal Cohort on Long-term Outcomes in RheumatIc diseAses

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

Chronic rheumatic diseases (CRDs) are major determinant of disability in the general population. Particularly, immune-mediated CRDs also represent a significant cause of morbidity and mortality among younger individuals. CRDs lead to substantial direct costs related to healthcare service use and pharmacological expenses, as well as indirect social costs. Proper prognostic stratification of CRD patients could tailor diagnostic and therapeutic interventions to improve clinical outcomes and strategically allocate healthcare resources while minimizing both direct and indirect costs. Reported prognostic predictors in CRDs are largely derived from randomized therapeutic trials and therefore mostly reflect short-term outcomes under controlled experimental conditions. A real-life research could provide crucial information about long-term outcomes including survival, impact of comorbidities and polypharmacotherapy, and inform on healthcare costs. The Gemelli longitudinal cohort on Long-term Outcomes in Rheumatic Diseases (GLORIA) aims to define shared and disease-specific predictors of long-term disability, organ damage, mortality, and healthcare costs for patients under the care of the Division of Rheumatology at the Fondazione Policlinico Universitario A. Gemelli IRCCS - Catholic University of the Sacred Heart in Rome. This study will adopt an electronic database identified for collecting and analyze data (REDcap Research Electronic Data Capture platform), compliant with general data protection regulation (GDPR) law. Predictors will be selected from routinely collected demographic, clinical, laboratory, histological, and instrumental data. Additional blood samples may be collected from newly diagnosed patients or when diagnostic or therapeutic interventions are required according to clinical practice. Excepted for additional collection of peripheral blood, no additional procedure will be therefore performed.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

5000

Start Date

2025-04-07

Completion Date

2035-04-07

Last Updated

2025-04-17

Healthy Volunteers

Not specified

Interventions

OTHER

Standard of care

Standard of care according to national and international guideline or recommendations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, Italy