- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07682636
Keloid Pathogenesis And Fibroblast Activation Study (KPS)
Mechanisms Of Keloid Fibroblast Activation And Potential Therapeutic Targets: A Tissue-Based Translational Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background
Keloids are fibroproliferative disorders resulting from abnormal wound healing and are characterized by excessive fibroblast proliferation and abnormal collagen deposition. Although several signaling pathways, including transforming growth factor-beta (TGF-β), have been implicated in keloid development, the underlying molecular mechanisms remain incompletely understood.
Objectives
The primary objective of this study is to investigate the molecular mechanisms associated with abnormal fibroblast activation in keloids and to identify potential therapeutic targets by comparing keloid tissue with adjacent normal skin tissue.
Study Design
This is a prospective, single-center, observational study conducted at The Fourth Affiliated Hospital, Zhejiang University School of Medicine. Adult patients diagnosed with keloids and scheduled for surgical excision will be invited to participate after providing written informed consent.
Study Procedures
Residual surgical specimens, including keloid tissue and adjacent normal skin routinely removed during surgery, will be collected without any additional surgical procedures. Samples will be de-identified before laboratory analysis. Histological examination, gene expression analysis, protein expression analysis, and signaling pathway evaluation will be performed using standard laboratory techniques, including histopathology, PCR, and Western blotting.
Outcome Measures
The primary outcome is the differential expression of fibrosis-related signaling molecules and fibroblast activation markers between keloid tissue and normal skin. Secondary outcomes include histopathological differences, collagen deposition characteristics, and identification of potential molecular therapeutic targets.
Significance
This study is expected to improve understanding of the biological mechanisms underlying keloid formation and provide a scientific basis for the development of future targeted therapies.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Wang
- Número de teléfono: +86 18867961137
- Correo electrónico: wangshoujie@zju.edu.cn
Ubicaciones de estudio
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Jinhua, Porcelana
- Reclutamiento
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
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Contacto:
- Wang
- Número de teléfono: +86 18867961137
- Correo electrónico: wangshoujie@zju.edu.cn
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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:
- Clinically diagnosed with keloid.
- Age 18 years or older.
- Scheduled to undergo surgical treatment at the study hospital.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Severe systemic disease.
- History of neurologic disease, alcoholism, postherpetic neuralgia, HIV infection, hypothyroidism, diabetes mellitus, or prior cancer chemotherapy.
- Other skin diseases within 5 cm of the keloid lesion, such as eczema.
- Systemic treatment within 7 days before enrollment or keloid-specific treatment within 6 weeks before enrollment, including intralesional corticosteroid injection, cryotherapy, topical medication, or silicone gel sheeting.
- Hormone or immunosuppressive therapy within 3 months before enrollment.
- Pregnancy or breastfeeding.
- Considered unsuitable for participation by the investigator.
- Refusal to participate in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Keloid Tissue Group
Tissue samples obtained from keloid lesions excised during surgery from enrolled patients.
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Surgical tissue collection only, no intervention
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Adjacent Normal Skin Group
Normal skin tissue obtained from the same patients during surgical procedures, used as internal control.
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Surgical tissue collection only, no intervention
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Expression Levels Of Fibrosis-Related Markers
Periodo de tiempo: Up to 2028
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Comparison of expression levels of fibrosis-related and fibroblast activation markers (including TGF-β, α-SMA, collagen I, and related signaling molecules) between keloid tissue and adjacent normal skin using PCR, Western blot, and histological analysis.
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Up to 2028
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Histopathological Differences Between Keloid And Normal Skin
Periodo de tiempo: 2026-2028
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Evaluation of histological differences between keloid tissue and adjacent normal skin, including collagen deposition, fibroblast density, and tissue structure changes using hematoxylin and eosin staining.
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2026-2028
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Colaboradores e Investigadores
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
- Procesos Patológicos
- Enfermedades del tejido conectivo
- Cicatriz
- Fibrosis
- Enfermedades del colágeno
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades de la piel y del tejido conectivo
- Queloide
- Instalaciones de atención médica Fuerza laboral y servicios
- Bancos de espécimen biológicos
- Instalaciones de salud
- Bancos de tejidos
Otros números de identificación del estudio
- KY-2026-115 (Otro identificador: The Fourth Affiliated Hospital, Zhejiang University School of Medicine)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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