Total Body Dermoscopic Evaluation of Pregnancy-related Changes in Melanocytic Nevi Using the FotoFinder ATBM Master System and the Impact of Artificial Intelligence Assisted Examinations on the Patients' Skin Cancer Screening Experience: A Prospective Two-arm Controlled Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in macroscopic aspect of melanocytic nevi
研究概览
简要总结
This study is
- to analyze whether more changes in melanocytic nevi (MN) occur in women during and after pregnancy compared to non-pregnant women of the same age
- and to analyze psychological effects of total body mapping and dermoscopic examination assisted by artificial intelligence during pregnancy.
详细描述
Melanocytic nevi (MN) are believed to undergo macroscopic and dermoscopic alterations during pregnancy. Possible changing features previously observed include color, pigment network, size, vascularization and the emerging of dots and globules. Recent studies have reported of melanoma being associated with increased mortality in pregnant women when compared to non-pregnant women. The new FotoFinder® ATBM master device provides the combination of total body mapping with deep learning-driven body scan algorithm which identifies all pigmented skin lesions of the body surface by pattern recognition software and supplies a risk assessment score (0.0-1.0; 0 indicating no suspicion for melanoma, 1 indicating a high suspicion for melanoma).
This study is
- to analyze whether more changes in melanocytic nevi (MN) occur in women during and after pregnancy compared to non-pregnant women of the same age
- and to analyze psychological effects of total body mapping and dermoscopic examination assisted by artificial intelligence during pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant female participants beyond the 12th week of pregnancy
- •Non-pregnant female participants
排除标准
- •Fitzpatrick skin phototypes V and VI
- •less than 15 MN (MN with a diameter less than 2mm will not be taken into account)
- •insufficient knowledge of project language (German, English, French)
- •inability to give consent.
结局指标
主要结局
Change in macroscopic aspect of melanocytic nevi
时间窗: for pregnant women: Visit 1 (between the 12th and 16th week of pregnancy), Visit 2 (between the 29th and 33rd week of pregnancy), Visit 3 (between 8 to 12 weeks after delivery). Non- pregnant women: Visit 1, Visit 2 (17 to 21 weeks after Visit 1)
Change in macroscopic aspect of melanocytic nevi
Change in mole analyzer score with the 2D FotoFinder ATBM master system
时间窗: for pregnant women: Visit 1 (between the 12th and 16th week of pregnancy), Visit 2 (between the 29th and 33rd week of pregnancy), Visit 3 (between 8 to 12 weeks after delivery). Non- pregnant women: Visit 1, Visit 2 (17 to 21 weeks after Visit 1)
mole analyzer score (0.0-1.0; 0 indicating no suspicion for melanoma, 1 indicating a high suspicion for melanoma)
次要结局
- Change in number of new malignant melanoma(for pregnant women: Visit 1 (between the 12th and 16th week of pregnancy), Visit 2 (between the 29th and 33rd week of pregnancy), Visit 3 (between 8 to 12 weeks after delivery). Non- pregnant women: Visit 1, Visit 2 (17 to 21 weeks after Visit 1))
- Change in psychological impact of skin cancer screening by descriptive analyzes of participants questionnaire(for pregnant women: Visit 1 (between the 12th and 16th week of pregnancy), Visit 2 (between the 29th and 33rd week of pregnancy), Visit 3 (between 8 to 12 weeks after delivery). Non- pregnant women: Visit 1, Visit 2 (17 to 21 weeks after Visit 1))