A Phase 1/2 interventional study of Blood Sampling for ctDNA Analysis in Melanoma and Skin Cancer, sponsored by Institute of Oncology Ljubljana. Active, not recruiting at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Institute of Oncology Ljubljana · Phase 1/2, Interventional, and Diagnostic
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.
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 176 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →Institute of Oncology Ljubljana is the lead sponsor of 88 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
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.
Other: Blood Sampling for ctDNA Analysis
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.
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.
Time frame: Baseline and during follow-up up to 24 months
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).
Time frame: From baseline up to 24 months
Plan to share: No
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This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Institute of Oncology Ljubljana