NCT03080948已完成不适用
Cutaneous Melanoma Risk Stratification of Individuals With a High-Risk Nevus Phenotype
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 4
- 主要终点
- number of patients having specific dermoscopic patterns
研究概览
简要总结
The investigators are doing this study to improve our ability to identify which people with many moles on their skin are most likely to develop skin melanoma. The investigators hope to identify features of moles that are associated with melanoma risk. The investigators hope to use this information to customize and tailor melanoma screening to the individual patient based on a better estimate of their individual risk.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Patients ≥ 18 years of age
- •High-risk nevus phenotype (≥ 50 nevi (≥ 2mm in size) and ≥ 1 atypical nevus)
- •First presented to MSKCC for cutaneous melanoma-related care on or after April 2016
- •Cases: diagnoses of unequivocal invasive cutaneous melanomas (AJCC Stages I-IV) confirmed by MSKCC pathology on or after April 2016
- •Cases: completion of surgical treatment of primary melanoma
- •Ability to sign or verbally consent to the informed consent
排除标准
- •Controls: Histopathologically borderline melanocytic tumors for which melanoma could not be excluded or that were treated as possible melanomas.
- •Known germline high-penetrance melanoma predisposition mutation (that is, CDKN2A, CDK4, and BAP1)
- •Cases: history of invasive cutaneous melanoma (AJCC Stages I-IV) not confirmed by MSKCC pathology
- •History of acrolentiginous type of cutaneous melanoma or history of mucosal melanoma
- •Cases and controls: prior administration of systemic medications known to modify nevus phenotype, including but not limited to: MEK inhibitors (trametinib, cobimetinib, etc.), BRAF inhibitors (vemurafenib, dabrafenib, etc.), and immunotherapy (pembrolizumab, nivolumab, atezolizumab, ipilimumab, etc.). Controls: history of Stage 0-IV melanoma confirmed by MSKCC pathology
- •History of limb amputation or other condition (e.g., tattoos, burns) per investigator discretion that would modify nevus phenotype
- •Physical inability to undergo total body photography or reflectance confocal microscopy imaging (that is, remain relatively still for durations of 3-5 minutes)
- •Known hypersensitivity to adhesive rings used for reflectance confocal microscopy
- •Inability to give informed consent
- •Have skin afflicted with anther skin condition (for example, psoriasis) that would affect ability to characterize nevus phenotype (per investigator discretion)
- •Familial cutaneous melanoma history (families with at least one invasive melanoma and two or more other diagnoses of invasive melanoma or pancreatic cancer among first- or second-degree relatives on the same side of the family). We will confirm melanoma family history via medical record documentation, whenever possible, as recommended by previous studies that disproved about half of the reported family histories of melanoma among first-degree relatives in case-control studies.
- •Age 70 or above
结局指标
主要结局
number of patients having specific dermoscopic patterns
时间窗: 2 years
For each person, the proportions of their nevi having specific dermoscopic patterns will be calculated.
次要结局
未报告次要终点
研究者
研究点 (4)
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