Genetic Risk Stratification of Pediatric Skin Lesions
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Presence or absence of PRAME genetic marker.
研究概览
简要总结
A study to understand the clinical utility of noninvasive adhesive skin biopsies in pediatric patients by exploring whether DermTech Pigmented Lesion Assay (PLA) genetic risk analysis of suspicious lesions in children correlates with histopathological diagnosis.
详细描述
Patients (20 years of age or younger) with one or more atypical skin lesions requiring surgical biopsy within the next 6 months will be enrolled in the study. Prior to surgical biopsy, a DermTech PLA noninvasive adhesive will be performed on the lesion. The results of DermTech PLA genetic analysis will be compared to the results of histopathological diagnosis from surgical biopsy. Incidents of adverse events will also be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years of age or younger.
- •Subjects or parents willing and able to give informed consent, and assent as appropriate
- •Patients will have one or more atypical skin lesions with management plan of monitoring, surgical biopsy, and/or excision of atypical nevi within the next 6 months
排除标准
- •Lesions on palms, soles, mucosal membranes, or area where hair cannot be trimmed
- •Bleeding or ulcerated lesions
- •Previously biopsied, scarred, or known melanoma lesions
- •Presence of active psoriasis/eczema/other skin condition in area to be biopsied
研究组 & 干预措施
DermTech PLA noninvasive adhesive biopsy
Prior to surgical biopsy, a DermTech PLA noninvasive adhesive will be pressed over the lesion to collect superficial skin cells.
干预措施: DermTech PLA noninvasive adhesive biopsy (Diagnostic Test)
结局指标
主要结局
Presence or absence of PRAME genetic marker.
时间窗: 1 day
Presence or absence of PRAME genetic marker from PLA test
Presence or absence of LINC genetic marker.
时间窗: 1 da7
Presence or absence of LINC genetic marker from PLA test
次要结局
- Incidence of Treatment-Emergent Adverse Events(1 day)
研究者
Elena Hawryluk
Principal Investigator
Massachusetts General Hospital