Early Diagnosis of Melanoma Using Expression Profiling and Non-Invasive Sampling of Skin Cells
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- A successful outcome of this proposal would create a candidate non-invasive diagnostic assay based on a gene expression profile for identifying early stage melanomas.
研究概览
简要总结
This study is divided into distinct sample collection and analysis phases. In the sample collection phase investigators will tape strip lesions that are designated for biopsy because they are suspected for melanoma. No biopsies will be taken solely in support of this study; rather patients that present lesions that are to be biopsied-in the context of the standard of care-will be enrolled in the study and will have that lesion(s) tape stripped before the biopsy procedure.
In the second phase of the study, tape strip samples will be extracted and RNA purified and expression profiled by DNA microarray. The gene expression data will be correlated with histopathology with the expectation that an expression classifier that distinguishes suspect lesions from melanoma can be defined. That classifier will be validated in future studies.
详细描述
This is a multi-center study, sponsored by Derm Tech (DTI) International.
Specific Aims of the study
This research study proposes to use a non-invasive method to capture superficial cells on pigmented skin lesions that are suspected of being early melanomas. This non-invasive "biopsy" technology has been developed and patented by DermTech International. RNA in skin cells captured by this method will be profiled in order to diagnose the nature of the lesion (i.e. malignant melanoma or not). A successful outcome of this proposal would create a candidate non-invasive diagnostic assay based on a gene expression profile for identifying early stage melanomas. This assay and more in particular the diagnostic gene expression profile are considered candidate because the profile would have to be validated (i.e. proven to be diagnostic) in larger clinical trials. Secondary outcomes could include tests for diagnosis and prognosis of a variety of pigmented skin lesions.
Specific Aim 1: To create a sample set of pigmented skin lesions. Each sample consisting of:
- RNA recovered by tape stripping the superficial epidermis overlying the lesion (tape stripping will also be used to recover RNA from normal skin areas and benign nevi as controls).
- A standard biopsy of the same lesion and accompanying histology and diagnosis. Biopsies would be taken after tape stripping and subjected to standard histopathologic analysis, which would provide a "gold standard" diagnosis. These diagnoses could then be correlated with the data generated in Specific
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject will be eligible if he or she:
- •Is at least 18 years of age;
- •Has a pigmented lesion that is suspected of being a melanoma and requires surgical removal.
排除标准
- •The subject cannot participate in this study if he or she:
- •Has used topical medications (corticosteroids, alpha-hydroxyacids, or retinoids) within 30 days of beginning the research study;
- •Has generalized skin disorders not related to skin cancer such as psoriasis, photosensitivity disorder or eczema;
- •Has allergy to tape or latex rubber.
研究组 & 干预措施
A
This research study proposes to use a non-invasive method to capture superficial cells on pigmented skin lesions that are suspected of being early melanomas. This non-invasive "biopsy" technology has been developed and patented by DermTech International. RNA in skin cells captured by this method will be profiled in order to diagnose the nature of the lesion (i.e. malignant melanoma or not). A successful outcome of this proposal would create a candidate non-invasive diagnostic assay based on a gene expression profile for identifying early stage melanomas
干预措施: EGIR Tape (Other)
结局指标
主要结局
A successful outcome of this proposal would create a candidate non-invasive diagnostic assay based on a gene expression profile for identifying early stage melanomas.
时间窗: 1 year
次要结局
未报告次要终点