LUpus Eritematoso Sistemico NETwork and Registry

NCT ID: NCT07175610

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2035-12-31

Brief 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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• age ≥ 18 years;
• confirmed SLE diagnosis according to the SLICC 2012 and/or ACR/EULAR 2019 classification criteria;
• provision of signed written informed consent prior to participation

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Società Italiana di Allergologia, Asma e Immunologia Clinica

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amato de Paulis

Role: STUDY_CHAIR

Division of Internal Medicine and Clinical Immunology, Center for Basic and Clinical Immunology Research (CISI), University of Naples Federico II, Naples, Italy

Locations

SOD Clinica Medica, Dip. Medicina Interna- Ospedali Riuniti Marche-AOU delle Marche

Ancona, , Italy

Medicina Interna Universitaria (Guido Baccelli) Azienda Ospedaliera Policlinico Consorziale

Bari, , Italy

U.O. di Medicina, Ospedale Civile "Santa Maria della Sapienza"

Battipaglia, , Italy

Allergologia e Immunologia Clinica, Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, , Italy

Struttura organizzativa Dipartimentale Complessa Immunologia e Terapie Cellulari, A.O.U. Careggi

Florence, , Italy

Struttura complessa Allergologia Immunologia Clinica e Reumatologia.Azienda Socio Sanitaria Territoriale di Mantova

Mantova, , Italy

Unità di Immunologia, Reumatologia, Allergologia e Malattie Rare all'IRCCS Ospedale San Raffaele di Milano

Milan, , Italy

Division of Internal Medicine and Clinical Immunology, Azienda Ospedaliera Universitaria Federico II

Napoli, , Italy

SYNERGO - Institute of Clinical Immunotherapy and Advanced Biological Treatmets-Casa di Cura Pierangeli S.r.l.

Pescara, , Italy

UO Immunoallergologia clinica, Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

UOC di Medicina Interna e Nutrizione Clinica -Policlinico Umberto I

Roma, , Italy

Reumatologia e Immunologia Clinica, Humanitas Research Hospital

Rozzano, , Italy

UOC Clinica Immunologica e Reumatologica, A.O.U. San Giovanni di Dio e Ruggi d'Aragona

Salerno, , Italy

SC (U.C.O.) Medicina Clinica Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)

Trieste, , Italy

SCDU Immunologia e Allergologia AO Ordine Mauriziano, University of Turin

Turin, , Italy

Medicina Interna B - Azienda Ospedaliera Universitaria Integrata

Verona, , Italy

Countries

Italy

Central Contacts

Concetta Sirena

Role: CONTACT

ricerche@siaaic.org

+39 02 4969 5358

References

Mormile I, Brussino L, Canonica GW, Cortini F, Costantino MT, Dagna L, Del Giacco S, Della Casa F, Di Gioacchino M, Emmi G, Moroncini G, Negrini S, Pacella D, Parronchi P, Patella V, Rossi FW, Sirena C, Triggiani M, Vacca A, de Paulis A. The LUNET Project: Developing the Italian Systemic Erythematous Lupus Network. J Clin Med. 2025 Sep 2;14(17):6197. doi: 10.3390/jcm14176197.

Reference Type: BACKGROUND

PMID: 40943959 (View on PubMed)

Other Identifiers

5

Identifier Type: -

Identifier Source: org_study_id