Liquid Biopsy Multi-Omics and Biomarker Development in Melanoma
ConditionMelanoma (Skin Cancer)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorXijing Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Participants will be selected from outpatients and inpatients at the Department of Dermatology, Xijing Hospital. Eligible participants are male and female adults aged 18-80 years with histopathologically confirmed acral or cutaneous melanoma according to the Melanoma Diagnosis and Treatment Guidelines. All participants have undergone sentinel lymph node biopsy with complete information available, retain archived melanoma tissue samples, and are scheduled to receive standard first-line immunotherapy. Participants with mucosal melanoma, severe organ dysfunction, immunodeficiency, a history of other concurrent malignancies, or incomplete clinical data will be excluded.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Melanoma Liquid Biopsy Cohor
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS)
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.
Time frame
From date of enrollment until date of progression or death, assessed up to 36 months.2
Overall survival (OS)
OS is defined as the time from enrollment to death from any cause.
Time frame
From date of enrollment until date of death, assessed up to 36 months.Secondary outcomes
1
Circulating tumor cell (CTC) count
Number of CTCs isolated from peripheral blood using surface antigen-independent microfluidic separation and enumerated.
Time frame
Baseline and after completion of treatment (up to 3 months)2
Circulating tumor DNA (ctDNA) concentration
Concentration of ctDNA in plasma, quantified by digital PCR or next-generation sequencing.
Time frame
Baseline and after completion of treatment (up to 3 months)3
Exosomal PD-L1 expression level
Concentration of PD-L1 on exosomes isolated by ultracentrifugation and quantified by immuno-multiplex fluorescence analysis.
Time frame
Baseline and after completion of treatment (up to 3 months)4
Sum of diameters of target lesions
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.
Time frame
Baseline and every 12 weeks through study completion (up to 36 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Xijing Hospital
Lead sponsor
Southern University of Science and Technology
Collaborator
Source ClinicalTrials.gov