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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07573735
Assessment of cfDNA-STING Axis as a Potential Pathological Marker in Atopic Dermatitis
An Observational Study on the Correlation Between Circulating Cell-free DNA and Skin Macrophage STING Pathway Activation in Patients With Atopic Dermatitis
Study Overview Atopic dermatitis (AD), commonly known as eczema, is a chronic inflammatory skin condition characterized by intense itching and skin barrier damage. While researchers know that the immune system is overactive in AD, it is difficult to measure the exact level of "damage" or "inflammation" happening deep within the skin using only a physical exam.
The Purpose of This Study This study investigates a specific "danger signal" called circulating cell-free DNA (cfDNA). When skin cells are damaged or die due to inflammation, they release tiny fragments of DNA into the bloodstream. The investigators believe these fragments might act as a trigger for the immune system, worsening the disease.
What the Study Involves Researchers will collect blood samples and small skin biopsies from patients with AD and healthy volunteers.
The study aims to: Compare the levels of cfDNA in the blood of AD patients versus healthy individuals. Determine if higher levels of cfDNA correlate with more severe skin symptoms (measured by scores like SCORAD and EASI). Examine how immune cells in the skin (macrophages) respond to these DNA fragments through a specific biological switch called the STING pathway.
Potential Impact By understanding this "damage-signal" loop, this research may lead to new ways for doctors to monitor AD severity through simple blood tests and could identify new targets for future anti-inflammatory treatments.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Scientific Rationale AD is primarily driven by Type 2 (Th2) immune responses; however, the role of innate immune sensing of damage-associated molecular patterns (DAMPs) in maintaining chronic inflammation is less defined. Cell-free DNA (cfDNA) has emerged as a potent DAMP in various autoimmune conditions. This study explores the hypothesis that cfDNA released during epidermal injury and inflammatory cell turnover in AD serves as a ligand for the cyclic GMP-AMP synthase (cGAS) - Stimulator of Interferon Genes (STING) pathway within the skin microenvironment.
Study Objectives Quantification of Systemic DAMPs: To quantify plasma cfDNA concentrations in a cohort of AD patients (n=40) compared to age- and sex-matched healthy controls (n=40) using fluorometric assays. Tissue-Level Mechanism: To characterize the local immune landscape via immunofluorescence (IF) staining of skin biopsies. The study focuses on the infiltration density of CD68+ macrophages and the expression/co-localization of STING protein within these cells.
Methodology Clinical Assessment: Patients undergo standardized dermatological evaluation to determine disease severity. Bio-sampling: Peripheral blood is collected for baseline hematology and cfDNA isolation. For a subset of patients, 4mm punch biopsies are taken from active lesional skin. Data Analysis: Cross-sectional analysis will be used to determine the diagnostic value of cfDNA and its ability to stratify disease severity (Moderate vs. Severe AD). Immunohistochemical quantification will be used to verify the activation of the STING pathway in situ.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Jiangsu
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Nanjing, Jiangsu, Porcelana
- Reclutamiento
- Zhongda Hospital, Southeast University
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Contacto:
- meihong Da
- Número de teléfono: 025-83272015
- Correo electrónico: huyk1997@163.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age 18 years or older
- Confirmed diagnosis of Atopic Dermatitis
Exclusion Criteria:
- Use of systemic immunosuppressants, systemic corticosteroids, or biological agents within 4 weeks prior to enrollment
- Use of topical treatments within 2 weeks prior to enrollment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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AD
This group consists of patients diagnosed with Atopic Dermatitis (AD) according to the Hanifin and Rajka criteria or the Williams diagnostic criteria.
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One-time peripheral venous blood collection and/or 4mm punch biopsy for biomarker analysis.
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Control
This group consists of healthy volunteers with no personal or family history of atopic dermatitis, asthma, allergic rhinitis, or other systemic inflammatory and autoimmune diseases.
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One-time peripheral venous blood collection and/or 4mm punch biopsy for biomarker 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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cfDNA
Periodo de tiempo: enrollment
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the quantification of circulating cell-free DNA
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enrollment
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Dong L, Hou YR, Xu N, Gao XQ, Sun Z, Yang QK, Wang LN. Cyclic GMP-AMP synthase recognizes the physical features of DNA. Acta Pharmacol Sin. 2025 Feb;46(2):264-270. doi: 10.1038/s41401-024-01369-7. Epub 2024 Aug 7.
- Decout A, Katz JD, Venkatraman S, Ablasser A. The cGAS-STING pathway as a therapeutic target in inflammatory diseases. Nat Rev Immunol. 2021 Sep;21(9):548-569. doi: 10.1038/s41577-021-00524-z. Epub 2021 Apr 8.
- Kopfnagel V, Dreyer S, Zeitvogel J, Pieper DH, Buch A, Sodeik B, Rademacher F, Harder J, Werfel T. Free human DNA attenuates the activity of antimicrobial peptides in atopic dermatitis. Allergy. 2021 Oct;76(10):3145-3154. doi: 10.1111/all.14992. Epub 2021 Jul 16.
- Schuler CF 4th, Tsoi LC, Billi AC, Harms PW, Weidinger S, Gudjonsson JE. Genetic and Immunological Pathogenesis of Atopic Dermatitis. J Invest Dermatol. 2024 May;144(5):954-968. doi: 10.1016/j.jid.2023.10.019. Epub 2023 Dec 11.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
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
Términos MeSH relevantes adicionales
- Enfermedades Genéticas Congénitas
- Enfermedades del sistema inmunológico
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Enfermedades de la piel
- Enfermedades De La Piel Genéticas
- Enfermedades De La Piel Eccematosas
- Dermatitis
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Enfermedades de la piel y del tejido conectivo
- Dermatitis Atópica
- Eczema
- Técnicas de investigación
- Manejo de muestras
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Puntas
- Procedimientos quirúrgicos, operativo
- Recolección de muestras de sangre
Otros números de identificación del estudio
- 2025ZDSYLL537P01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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