Liquid Biopsy Multi-Omics and Biomarker Development in Melanoma

NCT07584291 | Recruiting DMC

• 1 other identifier: XJPF-LCY-V202604
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma (Skin Cancer)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Circulating tumor cell (CTC) count

  Baseline and after completion of treatment (up to 3 months)

• Circulating tumor DNA (ctDNA) concentration

  Baseline and after completion of treatment (up to 3 months)

• Exosomal PD-L1 expression level

  Baseline and after completion of treatment (up to 3 months)

• Sum of diameters of target lesions

  Baseline and every 12 weeks through study completion (up to 36 months)

• Pathological response rate

  At surgery after approximately 3 months of treatment.

Study Arms (1)

Melanoma Liquid Biopsy Cohor

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead
• Southern University of Science and Technology: collaborator

Study Sites (1)

Xijing Hospital, Air Force Medical University

Xi'an, Shaanxi, China

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Weinan Guo

CONTACT

+86-29-84775406; guown@fmmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

CN (1)