Pregnancy-related Changes in Melanocytic Nevi
Study Details
Study Description
Brief Summary
This study is
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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
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and to analyze psychological effects of total body mapping and dermoscopic examination assisted by artificial intelligence during pregnancy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| pregnant women
|
Other: standard-of-care clinical skin examination
inspection of melanocytic nevi by dermatologist
Diagnostic Test: 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.
Other: 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)
|
Other: standard-of-care clinical skin examination
inspection of melanocytic nevi by dermatologist
Diagnostic Test: 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.
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- 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 macroscopic aspect of melanocytic nevi
- Change in mole analyzer score with the 2D FotoFinder ATBM master system [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)
Secondary Outcome Measures
- 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 number of new malignant melanoma
- 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)]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pregnant female participants beyond the 12th week of pregnancy
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Non-pregnant female participants
Exclusion Criteria:
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Fitzpatrick skin phototypes V and VI
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less than 15 MN (MN with a diameter less than 2mm will not be taken into account)
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insufficient knowledge of project language (German, English, French)
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inability to give consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Basel, Department of Dermatology | Basel | Switzerland | 4031 |
Sponsors and Collaborators
- University Hospital, Basel, Switzerland
Investigators
- Principal Investigator: Lara Valeska Maul, Dr. med., University Hospital Basel, Department of Dermatology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-02494; th21Maul2