Clinical trial · Interventional
Circulating Tumor DNA in Melanoma Patients
Significance of Detection and Quantification of Circulating Tumor DNA in the Treatment of Melanoma Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Sampling for ctDNA Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- ctDNA Monitoring Cohort
- description
- 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.
- interventionNames
- Other: Blood Sampling for ctDNA Analysis
Primary outcomes (1)
- measure
- Correlation of ctDNA With Clinical and Histopathological Prognostic Parameters
- timeFrame
- Baseline and during follow-up up to 24 months
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available