Liquid Biopsy Multi-Omics and Biomarker Development in Melanoma

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• Progression-free survival (PFS) — 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.
• Overall survival (OS) — 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.

Trial sites (1)

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