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Liquid Biopsy Multi-Omics and Biomarker Development in Melanoma

12. maj 2026 opdateret af: Xijing Hospital

Multi-Omics Analysis of Liquid Biopsy and Development of Clinical Biomarkers in Melanoma: A Prospective Cohort Study

This prospective, observational cohort study aims to explore the multi-omics profiles of liquid biopsies and develop clinical biomarkers in melanoma. Two hundred participants with pathologically confirmed acral or cutaneous melanoma who are scheduled to receive standard first-line immunotherapy will be enrolled. Blood samples will be collected at baseline and every 3 weeks during treatment, along with radiological assessments every 12 weeks. Tumor tissue will be obtained at surgery after approximately 3 months of therapy. Using microfluidic-based circulating tumor cell isolation, exosome enrichment, ctDNA analysis, and integrative multi-omics approaches, the study will compare molecular features across primary tumors, metastases, and liquid biopsy components. The primary outcomes are progression-free survival and overall survival, assessed up to 36 months. Secondary outcomes include changes in circulating tumor cell counts, ctDNA concentrations, exosomal biomarker levels, pathological response rate at surgery, and the predictive accuracy of a multi-omics model for treatment response. The findings are expected to provide a basis for personalized monitoring and treatment strategies in melanoma.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Shaanxi
      • Xi'an, Shaanxi, Kina
        • Rekruttering
        • Xijing Hospital, Air Force Medical University
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants will be selected from outpatients and inpatients at the Department of Dermatology, Xijing Hospital. Eligible participants are male and female adults aged 18-80 years with histopathologically confirmed acral or cutaneous melanoma according to the Melanoma Diagnosis and Treatment Guidelines. All participants have undergone sentinel lymph node biopsy with complete information available, retain archived melanoma tissue samples, and are scheduled to receive standard first-line immunotherapy. Participants with mucosal melanoma, severe organ dysfunction, immunodeficiency, a history of other concurrent malignancies, or incomplete clinical data will be excluded.

Beskrivelse

Inclusion Criteria:

  • Diagnosed with acral or cutaneous melanoma according to the "Melanoma Diagnosis and Treatment Guidelines."
  • Underwent sentinel lymph node biopsy with complete information available.
  • Archived melanoma tissue samples available with complete information.
  • Complete basic demographic and clinical information.
  • Age 18-80 years, any sex.

Exclusion Criteria:

  • Patients with severe organic diseases, immunodeficiency disorders, organ absence, or organ transplantation.
  • Patients diagnosed with mucosal melanoma according to the "Melanoma Diagnosis and Treatment Guidelines."
  • Patients with other concurrent malignant tumors (e.g., basal cell carcinoma, lung cancer).
  • Incomplete patient information or pathological sample data.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Melanoma Liquid Biopsy Cohor

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free survival (PFS)
Tidsramme: From date of enrollment until date of progression or death, assessed up to 36 months.
PFS is defined as the time from enrollment to the first occurrence of disease progression (assessed by RECIST 1.1) or death from any cause, whichever occurs first.
From date of enrollment until date of progression or death, assessed up to 36 months.
Overall survival (OS)
Tidsramme: From date of enrollment until date of death, assessed up to 36 months.
OS is defined as the time from enrollment to death from any cause.
From date of enrollment until date of death, assessed up to 36 months.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Circulating tumor cell (CTC) count
Tidsramme: Baseline and after completion of treatment (up to 3 months)
Number of CTCs isolated from peripheral blood using surface antigen-independent microfluidic separation and enumerated.
Baseline and after completion of treatment (up to 3 months)
Circulating tumor DNA (ctDNA) concentration
Tidsramme: Baseline and after completion of treatment (up to 3 months)
Concentration of ctDNA in plasma, quantified by digital PCR or next-generation sequencing.
Baseline and after completion of treatment (up to 3 months)
Exosomal PD-L1 expression level
Tidsramme: Baseline and after completion of treatment (up to 3 months)
Concentration of PD-L1 on exosomes isolated by ultracentrifugation and quantified by immuno-multiplex fluorescence analysis.
Baseline and after completion of treatment (up to 3 months)
Sum of diameters of target lesions
Tidsramme: Baseline and every 12 weeks through study completion (up to 36 months)
Sum of the longest diameters for non-nodal target lesions and short-axis diameters for nodal target lesions, assessed by CT or MRI per RECIST 1.1.
Baseline and every 12 weeks through study completion (up to 36 months)
Pathological response rate
Tidsramme: At surgery after approximately 3 months of treatment.
Number of participants with pathological response (partial or complete) in resected tissue after approximately 3 months of treatment, as determined by histopathological analysis.
At surgery after approximately 3 months of treatment.
Predictive accuracy of multi-omics model for treatment response
Tidsramme: At 3months after treatment initiation.
Area under the receiver operating characteristic (ROC) curve of an integrated multi-omics model (combining clinical, imaging, and liquid biopsy features) for predicting objective response (complete or partial response per RECIST 1.1) at 6 months.
At 3months after treatment initiation.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Xijing Hospital

Samarbejdspartnere

Southern University of Science and Technology

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juli 2025

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

30. maj 2028

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • XJPF-LCY-V202604

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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