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Efficacy of First-Line Immunotherapy in Metastatic Melanoma in Slovenia and Identification of Predictive Biomarkers

RECRUITINGN/ASponsored by Institute of Oncology Ljubljana
Actively Recruiting
PhaseN/A
SponsorInstitute of Oncology Ljubljana
Started2021-05-01
Est. completion2026-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

This study evaluates the effectiveness of first-line immunotherapy in patients with metastatic melanoma treated at the Institute of Oncology Ljubljana in Slovenia. The main objectives are to assess treatment response rates, progression-free survival, and treatment safety, and to identify prognostic and predictive biomarkers associated with response to immunotherapy. Biological samples including blood, stool, and body fluids (if available) will be collected at predefined time points and analyzed for molecular tumor markers. Imaging assessments (CT or PET/CT) will be performed before treatment initiation and during follow-up to evaluate response. The study aims to improve identification of patient subgroups who benefit from immunotherapy and those who do not, supporting better personalized treatment strategies.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Age ≥ 18 years
* Metastatic (diffuse) melanoma
* Planned first-line immunotherapy treatment
* Signed informed consent for participation in the study

Exclusion Criteria:

* Age \< 18 years
* Inability to provide informed consent
* Any condition preventing participation or sample collection according to investigator judgment

Conditions3

CancerMelanomaMetastatic Melanoma

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