Liquid Biopsy Multi-Omics and Biomarker Development in Melanoma
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
| Condition(s) | Melanoma (Skin Cancer) |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 progr |
| Who can participate | 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. |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Xijing Hospital |
| Locations | Xi'an, Shaanxi, China |
| Start date | 2025-07-01 |
| NCT ID | NCT07584291 |
| Official listing | https://clinicaltrials.gov/study/NCT07584291 |