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| ID | Type | Description | Link |
|---|---|---|---|
| ERIDEK-0084/2021 | Other Identifier | Ethics Committee of the Institute of Oncology Ljubljana |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From baseline up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tanja Mesti, MD | Institute of Oncology Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Oncology Ljubljana | Ljubljana | 1000 | Slovenia |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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.
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |