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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregnant women |
| ||
| non-pregnant women (control group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard-of-care clinical skin examination | Other | inspection of melanocytic nevi by dermatologist |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Lara Valeska Maul, Dr. med. | University Hospital Basel, Department of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel, Department of Dermatology | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D009508 | Nevus, Pigmented |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D009506 | Nevus |
| D018326 | Nevi and Melanomas |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| skin assessment with the 2D FotoFinder ATBM master system | Diagnostic Test | 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 | Other | 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 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) |
| D018358 |
| Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |