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.
Study Type
OBSERVATIONAL
Enrollment
200
Xijing Hospital, Air Force Medical University
Xi'an, Shaanxi, China
RECRUITINGProgression-free survival (PFS)
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.
Time frame: From date of enrollment until date of progression or death, assessed up to 36 months.
Overall survival (OS)
OS is defined as the time from enrollment to death from any cause.
Time frame: From date of enrollment until date of death, assessed up to 36 months.
Circulating tumor cell (CTC) count
Number of CTCs isolated from peripheral blood using surface antigen-independent microfluidic separation and enumerated.
Time frame: Baseline and after completion of treatment (up to 3 months)
Circulating tumor DNA (ctDNA) concentration
Concentration of ctDNA in plasma, quantified by digital PCR or next-generation sequencing.
Time frame: Baseline and after completion of treatment (up to 3 months)
Exosomal PD-L1 expression level
Concentration of PD-L1 on exosomes isolated by ultracentrifugation and quantified by immuno-multiplex fluorescence analysis.
Time frame: Baseline and after completion of treatment (up to 3 months)
Sum of diameters of target lesions
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.
Time frame: Baseline and every 12 weeks through study completion (up to 36 months)
Pathological response rate
Number of participants with pathological response (partial or complete) in resected tissue after approximately 3 months of treatment, as determined by histopathological analysis.
Time frame: At surgery after approximately 3 months of treatment.
Predictive accuracy of multi-omics model for treatment response
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.
Time frame: At 3months after treatment initiation.
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