NCT07584291Recruiting
Liquid Biopsy Multi-Omics and Biomarker Development in Melanoma
Multi-Omics Analysis of Liquid Biopsy and Development of Clinical Biomarkers in Melanoma: A Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 13 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 7 May 2026
- Start date
- 1 Jul 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Xijing Hospital
- Diseases
- Melanoma
- NCT number
- NCT07584291
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 Jul 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with other concurrent malignant tumors (e.g., basal cell carcinoma, lung cancer).
Other illness
- Patients with severe organic diseases, immunodeficiency disorders, organ absence, or organ transplantation.
Other
- Patients diagnosed with mucosal melanoma according to the "Melanoma Diagnosis and Treatment Guidelines."
- Incomplete patient information or pathological sample data.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xijing Hospital, Air Force Medical University Coordinator of this site? Confirm its status | Xi’an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.