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- Ensaio Clínico NCT07682636
Keloid Pathogenesis And Fibroblast Activation Study (KPS)
Mechanisms Of Keloid Fibroblast Activation And Potential Therapeutic Targets: A Tissue-Based Translational Study
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Wang
- Número de telefone: +86 18867961137
- E-mail: wangshoujie@zju.edu.cn
Locais de estudo
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Jinhua, China
- Recrutamento
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
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Contato:
- Wang
- Número de telefone: +86 18867961137
- E-mail: wangshoujie@zju.edu.cn
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Expression Levels Of Fibrosis-Related Markers
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Histopathological Differences Between Keloid And Normal Skin
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KY-2026-115 (Outro identificador: The Fourth Affiliated Hospital, Zhejiang University School of Medicine)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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