Liquid Biopsy Multi-Omics and Biomarker Development in Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Melanoma (Skin Cancer). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multi-Omics Analysis of Liquid Biopsy and Development of Clinical Biomarkers in Melanoma: A Prospective Cohort Study
Overview
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.
Primary outcome measures
- Progression-free survival (PFS) [Time frame: From date of enrollment until date of progression or death, assessed up to 36 months.]
- Overall survival (OS) [Time frame: From date of enrollment until date of death, assessed up to 36 months.]
Secondary outcome measures (6)
- Circulating tumor cell (CTC) count [Time frame: Baseline and after completion of treatment (up to 3 months)]
- Circulating tumor DNA (ctDNA) concentration [Time frame: Baseline and after completion of treatment (up to 3 months)]
- Exosomal PD-L1 expression level [Time frame: Baseline and after completion of treatment (up to 3 months)]
- Sum of diameters of target lesions [Time frame: Baseline and every 12 weeks through study completion (up to 36 months)]
- Pathological response rate [Time frame: At surgery after approximately 3 months of treatment.]
- Predictive accuracy of multi-omics model for treatment response [Time frame: At 3months after treatment initiation.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Xijing Hospital, Air Force Medical University — Xi'an
Identifiers
NCT: NCT07584291 · XJPF-LCY-V202604