NCT07175610

LUpus Eritematoso Sistemico NETwork and Registry

The LUNET Project: the Italian Systemic Erythematous Lupus Network and Registry

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Società Italiana di Allergologia, Asma e Immunologia Clinica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The LUNET Registry is intended to serve as a comprehensive primary data source, capturing real-world longitudinal clinical information, and the heterogeneity of patient presentations that are often underrepresented in traditional clinical trials. Ultimately, the LUNET Registry will help to optimize SLE management in routine clinical practice by enabling the compilation of real-world evidence to inform clinical decision-making and health policy. Patients will be enrolled by secondary and tertiary care centres for SLE across Italy in a real-world clinical set-up.

Detailed description

The LUNET's specific objectives are as follows: * Planning and conducting epidemiological studies to evaluate the incidence and prevalence rates of different clinical manifestations of SLE, and to evaluate short- and long-term outcomes, including survival rates and organ dysfunction, injury, and failure * Promoting multicenter studies that will compare different patient subgroups based on clinical phenotypes and organ involvement, to attain insights regarding disease expression and progression * Describing the profile of patients with lupus nephritis in the national population, to improve guidelines on its systematic and standardized assessment. * Evaluating the presence of central and peripheral nervous system involvement in the national population of patients with SLE, assessing the type, frequency, and severity of neurological symptoms and objective signs, as well as the instrumental techniques used in clinical practice (e.g., Magnetic Resonance Imaging (MRI) * Assessing biomarker data to support early diagnosis and guide treatment choices * Improving screening techniques for early identification of organ damage in SLE patients * Improving early treatment strategies * Tracking adherence and response to therapy * Evaluating the short- and long-term real-life effectiveness and safety of old and novel drugs approved for SLE, overall and in groups of patients with specific phenotypes * Assessing SLE patients' quality of life according to clinical phenotype and treatment approach * Assessing how socioeconomic status impacts patients' access to healthcare and absenteeism in relation to the disease and various therapeutic approaches * Evaluating how different therapeutic strategies impact hospitalization * Assessing the influence of old and novel therapies on fertility, pregnancy, and breastfeeding * Monitoring cardiovascular risk in SLE patients by evaluating the associated comorbidities, prospective development of cardiovascular events, and biomarker levels (e.g., fasting blood glucose, hemoglobin A1c, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides and pro-BNP) * Evaluating bone metabolism in patients with SLE through assessment of laboratory measurements (e.g., vitamin D, calcium, phosphorus, calcinuria, and phosphaturia) and instrumental assessments, such as dual-energy X-ray absorptiometry (DEXA) scans * Monitoring the causes of death among SLE patients

Conditions

• Systemic Lupus Erythematous (SLE)

Timeline

• Start date: 2025-09-30
• Primary completion: 2026-12-31
• Completion: 2035-12-31
• First posted: 2025-09-16
• Last updated: 2025-09-16

Locations

16 sites across 1 country: Italy