Melanoma (Skin Cancer)
Conditions
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.
Interventions
None listed
Sponsors
Xijing Hospital
Southern University of Science and Technology
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | From date of enrollment until date of progression or death, assessed up to 36 months. | PFS is defined as the time from enrollment to the first occurrence of disease progression (assessed by RECIST 1.1) or death from any cause, whichever occurs first. |
| Overall survival (OS) | From date of enrollment until date of death, assessed up to 36 months. | OS is defined as the time from enrollment to death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Circulating tumor cell (CTC) count | Baseline and after completion of treatment (up to 3 months) | Number of CTCs isolated from peripheral blood using surface antigen-independent microfluidic separation and enumerated. |
| Circulating tumor DNA (ctDNA) concentration | Baseline and after completion of treatment (up to 3 months) | Concentration of ctDNA in plasma, quantified by digital PCR or next-generation sequencing. |
| Exosomal PD-L1 expression level | Baseline and after completion of treatment (up to 3 months) | Concentration of PD-L1 on exosomes isolated by ultracentrifugation and quantified by immuno-multiplex fluorescence analysis. |
| Sum of diameters of target lesions | Baseline and every 12 weeks through study completion (up to 36 months) | Sum of the longest diameters for non-nodal target lesions and short-axis diameters for nodal target lesions, assessed by CT or MRI per RECIST 1.1. |
| Pathological response rate | At surgery after approximately 3 months of treatment. | Number of participants with pathological response (partial or complete) in resected tissue after approximately 3 months of treatment, as determined by histopathological analysis. |
| Predictive accuracy of multi-omics model for treatment response | At 3months after treatment initiation. | Area under the receiver operating characteristic (ROC) curve of an integrated multi-omics model (combining clinical, imaging, and liquid biopsy features) for predicting objective response (complete or partial response per RECIST 1.1) at 6 months. |
Countries
China
Contacts
CONTACTWeinan Guo
Outcome results
None listed