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Active, Not Recruiting

NCT Number: NCT07422805

Circulating Tumor DNA in 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Cancer Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Sampling for ctDNA Analysis

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Recurrence or Progression of Melanoma

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Official study title

Significance of Detection and Quantification of Circulating Tumor DNA in the Treatment of Melanoma Patients

Acronym: ctDNA

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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