Liquid Biopsy Multi-Omics and Biomarker Development in Melanoma

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.

Study Overview

• Status: Recruiting
• Conditions: Melanoma (Skin Cancer)

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Weinan Guo; Phone Number: +86-29-84775406; Email: guown@fmmu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Recruiting
      • Xijing Hospital, Air Force Medical University
      • Contact: Weinan Guo; Phone Number: +86-29-84775406; Email: guown@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Melanoma Liquid Biopsy Cohor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-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.	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.	From date of enrollment until date of death, assessed up to 36 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating tumor cell (CTC) count	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	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	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	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	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	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.

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Collaborators: Southern University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma
• Other Study ID Numbers: XJPF-LCY-V202604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No