NEOSENT - Early Anti-PD-1 Therapy In Patients With High-Risk Stage II Melanoma And/Or Microsatellitosis: An Ambispective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Time to initiation of systemic therapy
研究概览
简要总结
This is an observational cohort study evaluating clinical and pathological outcomes in patients with high-risk stage II melanoma.
Patients are included after receiving treatment as part of routine clinical practice. Decisions about treatment, including whether to start anti-PD1 therapy before surgery, are made by the treating physician and are not influenced by the study.
The study compares outcomes between patients who started anti-PD1 therapy before surgery and those treated according to the usual timing in clinical practice.
No treatments are assigned as part of the study.
详细描述
This study evaluates the association between the timing of anti-PD1 therapy initiation and clinical outcomes in patients with high-risk stage II melanoma (stages IIB and IIC) and/or microsatellitosis.
The study is designed as an ambispective observational cohort, including both retrospective and prospective patients treated in routine clinical practice.
The retrospective cohort includes patients who were managed according to standard clinical practice, typically undergoing surgical treatment followed by systemic/adjuvant anti-PD1 therapy. The prospective cohort includes patients who initiated anti-PD1 therapy prior to surgery, based on the treating physician's clinical judgment.
All treatment decisions, including the timing of systemic therapy initiation, are made independently by the treating physician and are not influenced by the study protocol. No interventions are assigned as part of the study, and no experimental treatment strategies are implemented.
Patients are categorized according to the timing of anti-PD1 therapy initiation (before surgery or according to standard timing), and outcomes are compared descriptively between these groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •- Adults (≥18 years) with histologically confirmed cutaneous melanoma stage IIB or IIC or stage III (N1c), managed in routine clinical practice.
排除标准
- •Patients without sufficient clinical or follow-up data.
- •Patients who do not provide informed consent (for prospective cohort).
结局指标
主要结局
Time to initiation of systemic therapy
时间窗: Up to 12 months
Time from date of diagnosis to the start of systemic or adjuvant therapy.
次要结局
未报告次要终点