LUpus Eritematoso Sistemico NETwork and Registry
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Systemic Lupus Erythematous (SLE). Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The LUNET Project: the Italian Systemic Erythematous Lupus Network and Registry
Обзор
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.
Подробное описание
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
Первичные конечные точки
- Remission [Срок оценки: Every year to ten year]
- Disease activity [Срок оценки: Every year to ten year]
Критерии участия
Критерии включения
- 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
Критерии исключения
\-
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 16 центров
- SOD Clinica Medica, Dip. Medicina Interna- Ospedali Riuniti Marche-AOU delle Marche — Ancona
- Medicina Interna Universitaria (Guido Baccelli) Azienda Ospedaliera Policlinico Consorzial — Bari
- U.O. di Medicina, Ospedale Civile "Santa Maria della Sapienza" — Battipaglia
- Allergologia e Immunologia Clinica, Azienda Ospedaliero-Universitaria di Cagliari — Cagliari
- Struttura organizzativa Dipartimentale Complessa Immunologia e Terapie Cellulari, A.O.U. C — Florence
- Struttura complessa Allergologia Immunologia Clinica e Reumatologia.Azienda Socio Sanitari — Mantua
- Unità di Immunologia, Reumatologia, Allergologia e Malattie Rare all'IRCCS Ospedale San Ra — Milan
- Division of Internal Medicine and Clinical Immunology, Azienda Ospedaliera Universitaria F — Naples
- … и ещё 8 центров
Публикации
- 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. PMID 40943959
Идентификаторы
NCT: NCT07175610 · 5