Circulating Tumor DNA in Melanoma Patients

NCT07422805 | Active Not Recruiting Phase 1

• 2 other identifiers: ORI2025-40ERIDEK-0084/2021
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Skin Cancer

Keywords

Circulating Tumor DNA; ctDNA; Melanoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and during follow-up up to 24 months

Secondary Outcomes (1)

• Recurrence or Progression of Melanoma

  From baseline up to 24 months

Study Arms (1)

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.

Other: Blood Sampling for ctDNA Analysis

Interventions

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.

ctDNA Monitoring Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tanja Mesti, MD

  Institute of Oncology Ljubljana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 20, 2026
• Study Start: November 1, 2021
• Primary Completion: November 30, 2023
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)