Blood-based multi-omics for melanoma biomarker discovery
Multi-Omics Analysis of Liquid Biopsy and Development of Clinical Biomarkers in Melanoma: A Prospective Cohort Study
This study will test whether combining circulating tumor DNA, circulating tumor cells, and exosome analyses can track response and predict outcomes in adults with acral or cutaneous melanoma starting first-line immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT07584291 on ClinicalTrials.gov |
What this trial studies
This prospective observational cohort will enroll 200 adults with pathologically confirmed acral or cutaneous melanoma who are starting standard first-line immunotherapy. Blood samples will be collected at baseline and every three weeks, with radiological assessments every 12 weeks and tumor tissue obtained at surgery after about three months of therapy. The study uses microfluidic-based CTC isolation, exosome enrichment, ctDNA analysis, and integrative multi-omics methods to compare molecular features across primary tumors, metastases, and liquid biopsy components. Primary outcomes are progression-free survival and overall survival up to 36 months, with secondary outcomes tracking changes in CTC counts, ctDNA concentrations, and exosomal biomarker levels.
Who should consider this trial
Good fit: Adults aged 18–80 with pathologically confirmed acral or cutaneous melanoma who have sentinel lymph node information, available archived tumor tissue, complete clinical data, and are scheduled to start standard first-line immunotherapy are ideal candidates.
Not a fit: Patients with mucosal melanoma, concurrent other malignancies, severe organ disease, immunodeficiency, prior organ transplantation, or incomplete clinical or pathological data are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could provide earlier, minimally invasive signals of treatment response and progression to help personalize immunotherapy decisions.
How similar studies have performed: Previous studies using ctDNA and circulating tumor cells in melanoma have shown promising results for monitoring therapy, but integrating CTCs, exosomes and multi-omics across tumor and liquid compartments at this scale is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Xi'an, Shaanxi
- Xijing Hospital, Air Force Medical University — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Weinan Guo
- Email: guown@fmmu.edu.cn
- Phone: +86-29-84775406
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.