Imaging Modalities for Melanoma Screening and Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sensitivity of the imaging modalities
研究概览
简要总结
This trial studies how well MoleMapper, Visiomed, and confocal microscopy work in screening participants for melanoma. Analyzing images (photographs) made with three different portable imaging systems may be as good as a visit to a dermatologist's office for finding melanomas before they can spread.
详细描述
PRIMARY OBJECTIVE:
I. To assess the clinical utility of clinical images, digital dermoscopy images and in-vivo confocal microscopy for teledermatology.
SECONDARY OBJECTIVE:
I. To incorporate in vivo confocal images into the triage system in order to determine to what degree the information gathered in this modality changes the classification of a lesion assigned by a licensed dermatologist.
TERTIARY OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons who participate in the free skin cancer screening at the PDX Skincare Festival at Oregon Health & Science University (OHSU) in 2021/2022 (date pending) and are informed by a provider that they have a pigmented lesion for which a biopsy is recommended are potentially eligible to participate in this study.
- •Persons who participate in the free skin cancer screening at the War on Skin Cancer event at OHSU in 2021/2022 (date pending) or other dates and locations and are informed by a provider that they have a clinically benign or atypical nevi are eligible to participate in the imaging portion of this study. No biopsy will be offered to these participants.
- •Persons age 18-80 are eligible for the study
- •Persons of any sex can be enrolled.
- •Persons of any race are eligible but we anticipate that most participants will be Non-Hispanic whites due to the prevalence of melanoma and other skin cancers in this group.
- •Only persons who can provide signed statement of informed consent will be enrolled.
- •Persons who are identified in OHSU Dermatology clinics or through OHSU e-visit and e-consult platforms as having a skin lesion in need of a biopsy for skin cancer
- •Persons identified via the Melanoma Community Registry (MCR) (IRB approved: 00010561)
排除标准
- •Allergy to the anesthetic (lidocaine).
研究组 & 干预措施
Screening (imaging, biopsy)
Participants undergo imaging of suspicious moles via smartphone app MoleMapper/Sklip app/native smartphone camera app, digital dermoscopy, and confocal microscopy. Participants then receive lidocaine SC and undergo shave or punch biopsy of suspected melanomas.
干预措施: Confocal Microscopy (Other)
Screening (imaging, biopsy)
Participants undergo imaging of suspicious moles via smartphone app MoleMapper/Sklip app/native smartphone camera app, digital dermoscopy, and confocal microscopy. Participants then receive lidocaine SC and undergo shave or punch biopsy of suspected melanomas.
干预措施: Dermoscopy (Other)
Screening (imaging, biopsy)
Participants undergo imaging of suspicious moles via smartphone app MoleMapper/Sklip app/native smartphone camera app, digital dermoscopy, and confocal microscopy. Participants then receive lidocaine SC and undergo shave or punch biopsy of suspected melanomas.
干预措施: Imaging Procedure (Procedure)
Screening (imaging, biopsy)
Participants undergo imaging of suspicious moles via smartphone app MoleMapper/Sklip app/native smartphone camera app, digital dermoscopy, and confocal microscopy. Participants then receive lidocaine SC and undergo shave or punch biopsy of suspected melanomas.
干预措施: Lidocaine (Drug)
Screening (imaging, biopsy)
Participants undergo imaging of suspicious moles via smartphone app MoleMapper/Sklip app/native smartphone camera app, digital dermoscopy, and confocal microscopy. Participants then receive lidocaine SC and undergo shave or punch biopsy of suspected melanomas.
干预措施: Punch Biopsy (Procedure)
Screening (imaging, biopsy)
Participants undergo imaging of suspicious moles via smartphone app MoleMapper/Sklip app/native smartphone camera app, digital dermoscopy, and confocal microscopy. Participants then receive lidocaine SC and undergo shave or punch biopsy of suspected melanomas.
干预措施: Shave Biopsy (Procedure)
结局指标
主要结局
Sensitivity of the imaging modalities
时间窗: Up to 1 year
Sensitivity is defined as recommend immediate biopsy (red) lesions correctly identified as red by the dermatologists. The nature of statistical data analyses will be descriptive and exploratory to estimate effect sizes and their variation as well as generate hypotheses for the future study design. Sensitivity and specificity will be estimated along with exact 95% confidence intervals.
Specificity of imaging modalities
时间窗: Up to 1 year
Specificity is defined as green (follow-up at annual skin exam) or yellow lesions (recommend examination by dermatologist in 3 months) correctly identified. The nature of statistical data analyses will be descriptive and exploratory to estimate effect sizes and their variation as well as generate hypotheses for the future study design. Sensitivity and specificity will be estimated along with exact 95% confidence intervals.
次要结局
- Sensitivity by changes after consideration of in vivo reflectance mode confocal scanning laser microscopy (RCM) report(Up to 1 year)
- Specificity by changes after consideration of RCM report(Up to 1 year)
研究者
Sancy A Leachman, MD, PhD
Principal Investigator
OHSU Knight Cancer Institute