NCT07584291 Liquid Biopsy Multi-Omics and Biomarker Development in Melanoma
| NCT ID | NCT07584291 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xijing Hospital |
| Condition | Melanoma (Skin Cancer) |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-07-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07584291 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Melanoma (Skin Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07584291 currently recruiting?
Yes, NCT07584291 is actively recruiting participants. Contact the research team at guown@fmmu.edu.cn for enrollment information.
Where is the NCT07584291 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT07584291 clinical trial?
NCT07584291 is sponsored by Xijing Hospital. The trial plans to enroll 200 participants.
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