Melanoma (Skin Cancer)NCT07584291
Liquid Biopsy Multi-Omics and Biomarker Development in Melanoma
An observational study of Melanoma (Skin Cancer), run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Melanoma (Skin Cancer)
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 30 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital, Air Force Medical University
Xi'an, Shaanxi
Weinan Guo, +86-29-84775406, guown@fmmu.edu.cn
About this study
Official title: Multi-Omics Analysis of Liquid Biopsy and Development of Clinical Biomarkers in Melanoma: A Prospective Cohort Study
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.
- Conditions
- Melanoma (Skin Cancer)
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Melanoma Liquid Biopsy Cohor | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of enrollment until date of progression or death, assessed up to 36 months.
Overall survival (OS)
OS is defined as the time from enrollment to death from any cause.
Measured: From date of enrollment until date of death, assessed up to 36 months.
Secondary outcomes (6)
Circulating tumor cell (CTC) count
Number of CTCs isolated from peripheral blood using surface antigen-independent microfluidic separation and enumerated.
Measured: Baseline and after completion of treatment (up to 3 months)
Circulating tumor DNA (ctDNA) concentration
Concentration of ctDNA in plasma, quantified by digital PCR or next-generation sequencing.
Measured: Baseline and after completion of treatment (up to 3 months)
Exosomal PD-L1 expression level
Concentration of PD-L1 on exosomes isolated by ultracentrifugation and quantified by immuno-multiplex fluorescence analysis.
Measured: Baseline and after completion of treatment (up to 3 months)
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.
Measured: Baseline and every 12 weeks through study completion (up to 36 months)
Pathological response rate
Number of participants with pathological response (partial or complete) in resected tissue after approximately 3 months of treatment, as determined by histopathological analysis.
Measured: At surgery after approximately 3 months of treatment.
Predictive accuracy of multi-omics model for treatment response
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.
Measured: At 3months after treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Southern University of Science and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584291
- Sponsor's protocol ID
- XJPF-LCY-V202604
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Omics Analysis of Liquid Biopsy and Development of Clinical Biomarkers in Melanoma: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07584291
- Acronym / sponsor ID
- XJPF-LCY-V202604
- Conditions
- Melanoma (Skin Cancer)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Southern University of Science and Technology
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melanoma Liquid Biopsy Cohor | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-free survival (PFS)
Time frame: 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)
Time frame: 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.
6 secondary outcomes
Circulating tumor cell (CTC) count
Time frame: Baseline and after completion of treatment (up to 3 months)
Circulating tumor DNA (ctDNA) concentration
Time frame: Baseline and after completion of treatment (up to 3 months)
Exosomal PD-L1 expression level
Time frame: Baseline and after completion of treatment (up to 3 months)
Sum of diameters of target lesions
Time frame: Baseline and every 12 weeks through study completion (up to 36 months)
Pathological response rate
Time frame: At surgery after approximately 3 months of treatment.
Predictive accuracy of multi-omics model for treatment response
Time frame: At 3months after treatment initiation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma (Skin Cancer), run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weinan Guo (+86-29-84775406, guown@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From date of enrollment until date of progression or death, assessed up to 36 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.