Clinical Practice Utility Study to Assess DermTech's Non-Invasive Pigmented Lesion Assay to Detect and Track Lesions for Suspected Melanoma and to Determine Outcomes for up to 2 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- Proportion of subjects without surgical biopsy
研究概览
简要总结
This is a multi-center, sample collection study to follow clinically suspicious lesions to determine the outcome including surgical biopsy, removal, monitoring, etc. for up to 2 years after lesion identification. Subjects who had, or will have a DermTech Pigmented Lesion Assay completed on a lesion suspected of being melanoma are eligible for the study. Based on historical data, an expected melanoma rate of approximately 5% to 10% is anticipated.
详细描述
This is a multi-center, sample collection study to follow clinically suspicious lesions to determine the outcome including surgical biopsy, removal, monitoring, etc. for up to 2 years after lesion identification.
Subjects will be consented and enter the trial to have their suspicious lesion(s), biopsied via DermTech's adhesive patch biopsy and assessed with DermTech's non-invasive PLA, and followed up to 2 years per standard of care. Lesions must be photographed and/or the site of the lesion anatomically defined to permit follow-up of the lesion(s) and lesional site(s) during future visits.
Subjects will be followed per standard of care for lesion biopsy, excision, treatment and/or monitoring. Other than DermTech's non-invasive PLA of the lesion(s) no other study procedures will be performed and subjects will be treated according to the standard of care. The subject's medical management team should use standard of care, visual assessment changes (i.e., "ABCDE") and physician judgment for suspicious lesion characterization and monitoring when planning the subject's course of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females the treating physician chose to use the PLA on;
- •Presence of a lesion(s) that is suspicious for melanoma and a candidate for surgical biopsy that was previously biopsied with DermTech's adhesive patch biopsy and assessed via PLA;
- •Willing to permit subsequent PLA assays to be performed on suspicious lesions;
- •Willing to follow standard of care treatment for the lesion(s) as determined by the treating physician;
- •Subjects must be able to complete study visits required by the protocol (subject is not planning to relocate or travel thus prevent attendance at future study visits; and
- •Willing to provide informed consent to participate in this trial.
排除标准
- •Has confirmed melanoma or a suspicious lesion that required a surgical biopsy or excision prior to the intial PLA on that lesion of interest;
- •Has an ulcerated or bleeding lesion that could cofound the PLA results;
- •Has a suspicious lesion(s) in an area that was previously surgically biopsied;
- •The lesion(s) is on the palms, mucosal surface, or other area where adhesive patch biopsies cannot be performed;
- •Has an allergy to tape or latex rubber;
- •Receipt of any investigational drug therapy within four weeks of study enrollment, or concurrent participation in another interventional clinical study deemed by the treating physician to potentially influence this study; and
- •Documented substance abuse, any other significant medical condition or laboratory result that would indicate an unreasonable risk to the subject or potential interference with study procedures, or would negatively affect the patient's reliability and compliance with the study schedule of events. -
结局指标
主要结局
Proportion of subjects without surgical biopsy
时间窗: approximately up to 24 months
The proportion of subjects who exit the study without surgical biopsy out to approximately up to 24 months ± SOC
次要结局
- Results of PLA results compared to biopsy(approximately up to 24 months)