Evaluation of Clinical, Pathologic, and Molecular Determinants of Prognosis and Treatment Response in Patients With Metastatic Malignant Melanoma: A Multicenter Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 试验地点
- 2
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Histologically or cytologically confirmed metastatic malignant melanoma
- •Received ≥1 line of systemic therapy
- •Complete baseline and follow-up data
- •At least one measurable lesion or clinical response assessment
- •Managed between November 2022 - December 2024 at participating centers
排除标准
- •Incomplete clinical or pathological data
- •Uncertain or revised diagnosis
- •Metastasis developing outside the inclusion window
- •Another primary malignancy (except allowed types)
- •Lost to follow-up before first response assessment
研究组 & 干预措施
Multicenter Metastatic Melanoma Cohort
Includes adult patients diagnosed with metastatic malignant melanoma and treated between November 2022 and December 2024. Systemic therapies included immune checkpoint inhibitors (nivolumab, pembrolizumab, ipilimumab), BRAF/MEK targeted agents (dabrafenib, trametinib, vemurafenib, encorafenib, binimetinib), and chemotherapy (dacarbazine or temozolomide). Treatment was delivered per routine clinical practice; no experimental assignment occurred.
干预措施: Systemic Therapy for Metastatic Melanoma (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From treatment initiation to disease progression or death, up to December 2024.
Progression-Free Survival (PFS) is defined as the time from initiation of systemic therapy to the earliest date of radiologically or clinically documented disease progression or death from any cause. Disease progression will be determined based on imaging studies or clinical evaluations recorded in medical files. Patients alive without documented progression at last follow-up will be censored.
次要结局
- Overall Survival (OS)(From treatment initiation to death or last follow-up, up to December 2024.)
- Objective Response Rate (ORR)(From treatment initiation to best documented response, within November 2022 - December 2024.)
- Incidence of Dermatologic Adverse Events(From treatment initiation to last follow-up, up to December 2024.)
- Treatment Discontinuation Due to Toxicity(From treatment initiation to treatment discontinuation or last follow-up, up to December 2024.)
- Disease Control Rate (DCR)(From treatment initiation to best documented response assessment, within November 2022 - December 2024.)
- Impact of Dermatologic Adverse Events on Progression-Free Survival(From treatment initiation to progression or last follow-up, up to December 2024.)
研究者
Galip Can Uyar
Medical Oncologist
Ankara Etlik City Hospital