An observational study in Melanocytic Nevi (MN), sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by University Hospital, Basel, Switzerland · Observational
This study is
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
19 studies on the registry are indexed under Nevus, Pigmented; 6 are open to participants now.
This study's enrollment of 50 is close to the median of 50 across 11 observational studies indexed under Nevus, Pigmented.
Browse Nevus, Pigmented studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant volunteers recruited through the Department of Gynaecology and Obstetrics at the University Hospital of Basel and through study advertisement displayed at gynaecological practices in the city of Basel.
Non-pregnant volunteers recruited through study advertisement displayed at the University of Basel and at the Department of Dermatology at the University Hospital Basel and through an advertisement.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: standard-of-care clinical skin examination · Diagnostic Test: skin assessment with the 2D FotoFinder ATBM master system · Other: data collection by participant questionnaire
Other: standard-of-care clinical skin examination · Diagnostic Test: skin assessment with the 2D FotoFinder ATBM master system · Other: data collection by participant questionnaire
inspection of melanocytic nevi by dermatologist
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.
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.
Change in macroscopic aspect of melanocytic nevi
Change in macroscopic aspect of melanocytic nevi
Time frame: 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)
Time frame: 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 number of new malignant melanoma
Time frame: 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).
Time frame: 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)
Ran from Jan 2021 to primary completion in Jun 2021, 4 months.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland →