Actively Recruiting
Liquid Biopsy Multi-Omics and Biomarker Development in Melanoma
Led by Xijing Hospital · Updated on 2026-05-13
200
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
X
Xijing Hospital
Lead Sponsor
S
Southern University of Science and Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Liquid Biopsy Multi-Omics and Biomarker Development in Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 between 18 and 80 years, any sex
You will not qualify if you...
- Severe organic diseases, immunodeficiency disorders, organ absence, or organ transplantation
- Diagnosed with mucosal melanoma according to the Melanoma Diagnosis and Treatment Guidelines
- Presence of other concurrent malignant tumors such as basal cell carcinoma or lung cancer
- Incomplete patient information or pathological sample data
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xijing Hospital, Air Force Medical University
Xi'an, Shaanxi, China
Actively Recruiting
Research Team
W
Weinan Guo
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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