Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2021-01-15
2022-02-09
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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pregnant women
standard-of-care clinical skin examination
inspection of melanocytic nevi by dermatologist
skin assessment with the 2D FotoFinder ATBM master system
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.
data collection by participant questionnaire
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.
non-pregnant women (control group)
standard-of-care clinical skin examination
inspection of melanocytic nevi by dermatologist
skin assessment with the 2D FotoFinder ATBM master system
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.
data collection by participant questionnaire
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.
Interventions
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standard-of-care clinical skin examination
inspection of melanocytic nevi by dermatologist
skin assessment with the 2D FotoFinder ATBM master system
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.
data collection by participant questionnaire
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.
Eligibility Criteria
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Inclusion Criteria
* Non-pregnant female participants
Exclusion Criteria
* 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.
18 Years
40 Years
FEMALE
Yes
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Lara Valeska Maul, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Basel, Department of Dermatology
Locations
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University Hospital Basel, Department of Dermatology
Basel, , Switzerland
Countries
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Other Identifiers
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2020-02494; th21Maul2
Identifier Type: -
Identifier Source: org_study_id
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