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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07805863
Serum MPO-DNA Complexes as a Biomarker of Disease Activity in Systemic Lupus Erythematosus
Serum Myeloperoxidase-DNA Complexes as a Novel Biomarker of Neutrophil Extracellular Trap and Disease Activity in Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by immune system dysregulation and inflammation affecting multiple organs. A key mechanism in its development involves the excessive formation and impaired clearance of neutrophil extracellular traps (NETs), which release myeloperoxidase-DNA (MPO-DNA) complexes into the circulation. Although standard laboratory markers like complement proteins (C3, C4) and anti-dsDNA antibodies are routinely used, they often show inconsistent sensitivity in monitoring disease activity and flare-ups.
The primary purpose of this observational study is to evaluate serum MPO-DNA complexes as a circulating biomarker of NET formation in patients with systemic lupus erythematosus.
The study aims to:
- Measure serum MPO-DNA complex levels in active SLE patients compared to age- and sex-matched inactive SLE controls.
- Assess the correlation between MPO-DNA complex levels and clinical disease activity measured by the SLE Disease Activity Index 2000 (SLEDAI-2K) score.
- Evaluate the diagnostic accuracy of MPO-DNA complexes compared to conventional inflammatory and immunological markers (ESR, CRP, C3, C4, and anti-dsDNA).
Participants will undergo routine clinical assessments and standard blood sampling to measure routine laboratory parameters and circulating MPO-DNA complex levels via enzyme-linked immunosorbent assay (ELISA).
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Diagnosis of systemic lupus erythematosus (SLE) according to the 2019 European Alliance of Associations for Rheumatology/American College of Rheumatology (EULAR/ACR) classification criteria.
- Age older than 16 years.
- Provision of written informed consent prior to study enrollment.
Exclusion Criteria:
- Age 16 years or younger.
- Overlapping autoimmune diseases (e.g., rheumatoid arthritis, systemic sclerosis, mixed connective tissue disease).
- Concurrent active severe infections.
- Malignancy.
- Pregnancy.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Active SLE Patients
Consists of 45 patients clinically diagnosed with systemic lupus erythematosus according to the 2019 EULAR/ACR classification criteria, presenting with active disease as determined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K).
Serum samples are collected to measure circulating myeloperoxidase-DNA (MPO-DNA) complexes via ELISA alongside routine inflammatory and immunological markers.
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Inactive SLE Controls
Consists of 45 age- and sex-matched patients clinically diagnosed with systemic lupus erythematosus according to the 2019 EULAR/ACR classification criteria, presenting with inactive disease (clinical remission) based on SLEDAI-2K scoring.
Serum samples are collected to evaluate baseline circulating MPO-DNA complex levels and routine laboratory parameters for comparative analysis.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Serum Myeloperoxidase-DNA (MPO-DNA) Complex Concentration
Periodo de tiempo: Baseline
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Circulating levels of myeloperoxidase-DNA (MPO-DNA) complexes, measured in optical density (OD) units or ng/mL using an enzyme-linked immunosorbent assay (ELISA), to evaluate neutrophil extracellular trap (NET) formation and compare active versus inactive SLE patients.
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Baseline
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades del tejido conectivo
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Glomerulonefritis
- Nefritis
- Enfermedades de la piel y del tejido conectivo
- Lupus Eritematoso Sistémico
- Nefritis lúpica
Otros números de identificación del estudio
- MPO-DNA in Lupus Activity
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