MelanomaPhase 1/2ctDNANCT07422805
Circulating Tumor DNA in Melanoma Patients
A Phase 1/2 study testing Blood Sampling for ctDNA Analysis in people with Melanoma and Skin Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial summary
The aim of this prospective clinical study is to determine whether the presence and quantity of circulating tumor DNA (ctDNA) can serve as a predictive factor for recurrence or progression of melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Skin Cancer
- What is being tested?
- Blood Sampling for ctDNA Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Nov 2021to 30 Nov 2026
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥ 18 years).
- Patients with histologically confirmed melanoma.
- Patients undergoing treatment and/or follow-up at the Institute of Oncology Ljubljana.
- Availability of clinical follow-up data to assess recurrence or progression.
- Ability to provide blood samples for ctDNA analysis.
- Signed informed consent.
Who cannot join
- Patients unable to provide blood samples.
- Patients with missing clinical or histopathological data required for analysis.
- Any condition that, in the investigator's opinion, makes the patient unsuitable for participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Significance of Detection and Quantification of Circulating Tumor DNA in the Treatment of Melanoma Patients
The aim of this prospective clinical study is to determine whether the presence and quantity of circulating tumor DNA (ctDNA) can serve as a predictive factor for recurrence or progression of melanoma. The study evaluates the association between ctDNA detection and quantification and relevant clinical and histopathological prognostic parameters. The goal is to assess whether ctDNA may be useful as a biomarker for monitoring disease course and predicting outcomes in melanoma patients.
Read the detailed description
This is a prospective clinical study evaluating the clinical significance of circulating tumor DNA (ctDNA) detection and quantification in patients with melanoma. The main purpose of the study is to determine whether the presence and quantity of ctDNA may represent a predictive biomarker for melanoma recurrence or disease progression.
The study assesses the relationship between ctDNA levels and established clinical and histopathological prognostic factors. ctDNA detection and quantification are performed and correlated with relevant patient and tumor characteristics. The study also evaluates whether ctDNA measurement can contribute to improved monitoring of melanoma patients and prediction of disease course.
The study is conducted at the Institute of Oncology Ljubljana and includes melanoma patients who are followed over time.
- Conditions
- Melanoma, Skin Cancer
- Being tested
- Blood Sampling for ctDNA Analysis
- Keywords
- Circulating Tumor DNA, ctDNA, Melanoma
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sampling for ctDNA AnalysisOther
Peripheral blood samples are collected for detection and quantification of circulating tumor DNA (ctDNA). ctDNA results are evaluated in relation to clinical and histopathological prognostic parameters and to recurrence or progression of melanoma during follow-up.
| Study group | Role | What they receive |
|---|---|---|
| ctDNA Monitoring Cohort | Other | Patients with histologically confirmed melanoma are monitored for the presence and quantity of circulating tumor DNA (ctDNA) during follow-up in order to evaluate the association between ctDNA and recurrence or progression of disease. Receives: Other: Blood Sampling for ctDNA Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of ctDNA With Clinical and Histopathological Prognostic Parameters
Circulating tumor DNA (ctDNA) will be measured in peripheral blood plasma using a validated molecular assay (e.g., digital droplet PCR and/or next-generation sequencing). ctDNA will be reported as detectable vs. non-detectable and as ctDNA concentration (copies/mL). Correlation between ctDNA results and clinical/histopathological prognostic parameters (e.g., AJCC stage, Breslow thickness, ulceration status, and metastatic status) will be assessed.
Measured: Baseline and during follow-up up to 24 months
Secondary outcomes (1)
Recurrence or Progression of Melanoma
Melanoma recurrence or disease progression will be assessed based on clinical evaluation and imaging findings documented in the medical record. The outcome will be reported as the proportion of participants with recurrence/progression and correlated with ctDNA detectability and ctDNA concentration (copies/mL).
Measured: From baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Nov 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants are included in a single study group. Peripheral blood samples are collected for ctDNA detection and quantification, and ctDNA results are evaluated in relation to clinical and histopathological parameters and melanoma recurrence or progression during follow-up.
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanja Mesti, MD, Principal investigator, Institute of Oncology Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422805
- Sponsor's protocol ID
- ORI2025-40
- Other IDs
- ERIDEK-0084/2021
- Acronym
- ctDNA
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Significance of Detection and Quantification of Circulating Tumor DNA in the Treatment of Melanoma Patients
- ClinicalTrials.gov ID
- NCT07422805
- Acronym / sponsor ID
- ctDNA / ORI2025-40
- Conditions
- Melanoma, Skin Cancer
- Keywords
- Circulating Tumor DNA, ctDNA, Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 20 Feb 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.
The aim of this prospective clinical study is to determine whether the presence and quantity of circulating tumor DNA (ctDNA) can serve as a predictive factor for recurrence or progression of melanoma. The study evaluates the association between ctDNA detection and quantification and relevant clinical and histopathological prognostic parameters. The goal is to assess whether ctDNA may be useful as a biomarker for monitoring disease course and predicting outcomes in melanoma patients.
Detailed description
This is a prospective clinical study evaluating the clinical significance of circulating tumor DNA (ctDNA) detection and quantification in patients with melanoma. The main purpose of the study is to determine whether the presence and quantity of ctDNA may represent a predictive biomarker for melanoma recurrence or disease progression.
The study assesses the relationship between ctDNA levels and established clinical and histopathological prognostic factors. ctDNA detection and quantification are performed and correlated with relevant patient and tumor characteristics. The study also evaluates whether ctDNA measurement can contribute to improved monitoring of melanoma patients and prediction of disease course.
The study is conducted at the Institute of Oncology Ljubljana and includes melanoma patients who are followed over time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants are included in a single study group. Peripheral blood samples are collected for ctDNA detection and quantification, and ctDNA results are evaluated in relation to clinical and histopathological parameters and melanoma recurrence or progression during follow-up.
| Arm | Type | Receives |
|---|---|---|
| ctDNA Monitoring Cohort | Other | Other: Blood Sampling for ctDNA AnalysisPatients with histologically confirmed melanoma are monitored for the presence and quantity of circulating tumor DNA (ctDNA) during follow-up in order to evaluate the association between ctDNA and recurrence or progression of disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients (≥ 18 years).
- Patients with histologically confirmed melanoma.
- Patients undergoing treatment and/or follow-up at the Institute of Oncology Ljubljana.
- Availability of clinical follow-up data to assess recurrence or progression.
- Ability to provide blood samples for ctDNA analysis.
Key exclusion criteria (3 listed)
- Patients unable to provide blood samples.
- Patients with missing clinical or histopathological data required for analysis.
- Any condition that, in the investigator's opinion, makes the patient unsuitable for participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sampling for ctDNA AnalysisPeripheral blood samples are collected for detection and quantification of circulating tumor DNA (ctDNA). ctDNA results are evaluated in relation to clinical and histopathological prognostic parameters and to recurrence or progression of melanoma during follow-up. | Other | ctDNA Monitoring Cohort |
Primary outcome
Correlation of ctDNA With Clinical and Histopathological Prognostic Parameters
Time frame: Baseline and during follow-up up to 24 months
Circulating tumor DNA (ctDNA) will be measured in peripheral blood plasma using a validated molecular assay (e.g., digital droplet PCR and/or next-generation sequencing). ctDNA will be reported as detectable vs. non-detectable and as ctDNA concentration (copies/mL). Correlation between ctDNA results and clinical/histopathological prognostic parameters (e.g., AJCC stage, Breslow thickness, ulceration status, and metastatic status) will be assessed.
1 secondary outcome
Recurrence or Progression of Melanoma
Time frame: From baseline up to 24 months
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 27 May 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tanja Mesti, MD principal investigator
Institute of Oncology Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Blood Sampling for ctDNA Analysis in people with Melanoma and Skin Cancer, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 27 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 Slovenia. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of ctDNA With Clinical and Histopathological Prognostic Parameters (time frame: Baseline and during follow-up up to 24 months). 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 27 May 2026.