- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07682636
Keloid Pathogenesis And Fibroblast Activation Study (KPS)
Mechanisms Of Keloid Fibroblast Activation And Potential Therapeutic Targets: A Tissue-Based Translational Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Wang
- Numéro de téléphone: +86 18867961137
- E-mail: wangshoujie@zju.edu.cn
Lieux d'étude
-
-
-
Jinhua, Chine
- Recrutement
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
-
Contact:
- Wang
- Numéro de téléphone: +86 18867961137
- E-mail: wangshoujie@zju.edu.cn
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Keloid Tissue Group
Tissue samples obtained from keloid lesions excised during surgery from enrolled patients.
|
Surgical tissue collection only, no intervention
|
|
Adjacent Normal Skin Group
Normal skin tissue obtained from the same patients during surgical procedures, used as internal control.
|
Surgical tissue collection only, no intervention
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Expression Levels Of Fibrosis-Related Markers
Délai: Up to 2028
|
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.
|
Up to 2028
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Histopathological Differences Between Keloid And Normal Skin
Délai: 2026-2028
|
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.
|
2026-2028
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KY-2026-115 (Autre identifiant: The Fourth Affiliated Hospital, Zhejiang University School of Medicine)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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