Blood-based multi-omics for melanoma biomarker discovery
Official title: Multi-Omics Analysis of Liquid Biopsy and Development of Clinical Biomarkers in Melanoma: A Prospective Cohort Study
Run by Xijing Hospital · NCT07584291 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Xijing Hospital Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Xi'an, Shaanxi) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | May 30, 2028 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT07584291 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.