Circulating Tumor DNA in Melanoma Patients

Phase 2Active Not RecruitingNCT07422805

Institute of Oncology Ljubljana176 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

176

Conditions

Melanoma Skin Cancer

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institute of Oncology Ljubljana

Ljubljana, Slovenia

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.