A Prospective Registry Study of a Primary Melanoma Gene-signature to Predict Sentinel Node (SN) Status and Determine Its Prognostic Value for More Accurate Staging of SN-negative Melanoma Patients.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,820
- 试验地点
- 9
- 主要终点
- Positive Predictive Value (PPV)
研究概览
简要总结
MERLIN_001 is a prospective registry study of a primary melanoma gene-signature to predict sentinel node (SN) status and to determine its prognostic value for more accurate staging of SN-negative melanoma patients.
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
- •Newly diagnosed patients with invasive malignant melanoma of the skin (AJCC 8th edition staging guidelines) elected to undergo sentinel lymph node biopsy per the treating physician's recommendation.
- •Male or female, age ≥18 years.
排除标准
- •Full primary melanoma pathology report unavailable.
- •Documented clinically apparent nodal metastases at diagnosis.
- •Distant metastatic disease (M1a,b,c,d) clinically present at primary diagnosis
- •Any prior or concurrent primary invasive melanoma mapping to the same draining lymph node basin(s).
- •Documented history of another (prior or concurrent) primary invasive melanoma of T1b or greater at any site within the last 5 years.
- •Previous surgery in or radiation therapy to the draining lymph node basin(s) of the current primary melanoma.
- •Ocular, vulvar, perianal or mucosal melanomas or melanocytic tumors of uncertain malignant potential (MELTUMP) or atypical Spitz tumors.
结局指标
主要结局
Positive Predictive Value (PPV)
时间窗: 2 years after inclusion
The predictive capability of the Merlin Assay to identify newly diagnosed primary cutaneous melanoma patients who have a low risk of presenting with a positive sentinel lymph node.
Negative Predictive Value (NPV)
时间窗: 2 years after inclusion
The predictive capability of the Merlin Assay to identify newly diagnosed primary cutaneous melanoma patients who have a low risk of presenting with a positive sentinel lymph node.
Sensitivity and Specificity.
时间窗: 2 years after inclusion
The predictive capability of the Merlin Assay to identify newly diagnosed primary cutaneous melanoma patients who have a low risk of presenting with a positive sentinel lymph node.
次要结局
- 3-5 year Recurrence-Free Survival (RFS)(3-5 years after patient inclusion)
- 3-5 year Distant Metastasis-Free Survival (DMFS)(3-5 years after patient inclusion)
- 3-5 year Overall Survival (OS)(3-5 years after patient inclusion)