Melanoma, Skin Cancer
Conditions
Keywords
Circulating Tumor DNA, ctDNA, Melanoma
Brief 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. 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.
Interventions
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.
Sponsors
Institute of Oncology Ljubljana
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of ctDNA With Clinical and Histopathological Prognostic Parameters | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence or Progression of Melanoma | From baseline up to 24 months | 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). |
Countries
Slovenia
Contacts
PRINCIPAL_INVESTIGATORTanja Mesti, MD
Institute of Oncology Ljubljana
Outcome results
None listed