- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07682636
Keloid Pathogenesis And Fibroblast Activation Study (KPS)
Mechanisms Of Keloid Fibroblast Activation And Potential Therapeutic Targets: A Tissue-Based Translational Study
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Wang
- Telefonnummer: +86 18867961137
- E-post: wangshoujie@zju.edu.cn
Studiesteder
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Jinhua, Kina
- Rekruttering
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
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Ta kontakt med:
- Wang
- Telefonnummer: +86 18867961137
- E-post: wangshoujie@zju.edu.cn
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Expression Levels Of Fibrosis-Related Markers
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Histopathological Differences Between Keloid And Normal Skin
Tidsramme: 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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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KY-2026-115 (Annen identifikator: The Fourth Affiliated Hospital, Zhejiang University School of Medicine)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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