Pregnancy-related Changes in Melanocytic Nevi

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Melanocytic Nevi (MN)

Intervention / Treatment
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* Other: standard-of-care clinical skin examination
* Diagnostic Test: skin assessment with the 2D FotoFinder ATBM master system
* Other: data collection by participant questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant female participants beyond the 12th week of pregnancy Non-pregnant female participants Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pregnant women<br> | Other: standard-of-care clinical skin examination<br>* inspection of melanocytic nevi by dermatologist<br>Diagnostic Test: skin assessment with the 2D FotoFinder ATBM master system<br>* The 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).The integrated software analyzer scores regarding malignancy probability of the moles (FotoFinder® score: 0.0-1.0) will be collected.<br>Other: data collection by participant questionnaire<br>* At baseline, the participants will complete a questionnaire concerning their previous exposure to sun, their current sun-related protective behaviours, their history of skin check frequency and skin cancer at baseline. Additionally, in each consultation newly-created study-specific questions concerning the participants' examination experience, the sun-related protective behaviours and worries about skin cancer throughout the study will be investigated.<br>|
| non-pregnant women (control group)<br> | Other: standard-of-care clinical skin examination<br>* inspection of melanocytic nevi by dermatologist<br>Diagnostic Test: skin assessment with the 2D FotoFinder ATBM master system<br>* The 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).The integrated software analyzer scores regarding malignancy probability of the moles (FotoFinder® score: 0.0-1.0) will be collected.<br>Other: data collection by participant questionnaire<br>* At baseline, the participants will complete a questionnaire concerning their previous exposure to sun, their current sun-related protective behaviours, their history of skin check frequency and skin cancer at baseline. Additionally, in each consultation newly-created study-specific questions concerning the participants' examination experience, the sun-related protective behaviours and worries about skin cancer throughout the study will be investigated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in macroscopic aspect of melanocytic nevi | Change in macroscopic aspect of melanocytic nevi | 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 mole analyzer score with the 2D FotoFinder ATBM master system | mole analyzer score (0.0-1.0; 0 indicating no suspicion for melanoma, 1 indicating a high suspicion for 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of new malignant melanoma | 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 | Change in psychological impact of skin cancer screening by descriptive analyzes of participants questionnaire (investigating the subjective examination experience, the impact on skin cancer worries and the participants' sun protection and self-inspection behaviour). | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin cancer screening, total body mapping, deep learning-driven body scan, FotoFinder® ATBM master, malignant melanoma, pregnancy-related changes in melanocytic nevi