NCT07256184

Prognostic and Treatment-Response Factors in Metastatic Melanoma: Multi-Center Analysis

Evaluation of Clinical, Pathologic, and Molecular Determinants of Prognosis and Treatment Response in Patients With Metastatic Malignant Melanoma: A Multicenter Retrospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 232 (actual)
• Sponsor: Ankara Etlik City Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, retrospective observational study aims to identify clinical, pathological, and molecular factors associated with prognosis and treatment response in patients with metastatic malignant melanoma. Medical records of adult patients diagnosed and treated between November 2022 and December 2024 at participating oncology centers in Türkiye were reviewed. Data collected include demographic features, disease characteristics, histopathologic findings, treatment modalities (immune checkpoint inhibitors, targeted therapy, or chemotherapy), and dermatologic adverse events. These variables will be analyzed in relation to survival outcomes to provide real-world evidence supporting personalized management strategies in metastatic melanoma.

Detailed description

This multicenter retrospective cohort study evaluates clinical, pathological, and molecular factors that may influence prognosis and treatment response in patients with metastatic malignant melanoma treated between November 2022 and December 2024. The study focuses on routinely collected real-world data, including demographic characteristics, disease features, systemic treatment regimens, and dermatologic adverse events. The primary analytical objectives are to assess associations between baseline variables and treatment outcomes, including Progression-Free Survival (PFS), Overall Survival (OS), and Objective Response Rate (ORR). Dermatologic and systemic toxicities graded using CTCAE v5.0 will also be explored for their potential impact on treatment continuity and outcomes. The study uses descriptive statistics, survival analyses, and Cox regression models. No experimental interventions are assigned, and all treatments were delivered as part of routine clinical practice. This description provides an overview of study intent and analytic framework without duplicating detailed eligibility criteria or outcome definitions recorded in other submission fields.

Conditions

• Metastatic Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Systemic Therapy for Metastatic Melanoma	Standard systemic treatments administered for metastatic malignant melanoma, including immune checkpoint inhibitors (nivolumab, pembrolizumab, ipilimumab), targeted therapy (dabrafenib, trametinib, vemurafenib, encorafenib, binimetinib), and chemotherapy (dacarbazine or temozolomide regimens). All treatments were provided as part of routine institutional clinical practice. No investigational or randomized assignment was performed. Treatment information was collected retrospectively from medical records for evaluation of prognostic and treatment-response outcomes.

Timeline

• Start date: 2022-11-15
• Primary completion: 2024-12-15
• Completion: 2024-12-15
• First posted: 2025-12-01
• Last updated: 2025-12-15

Locations

2 sites across 1 country: Turkey (Türkiye)