Pregnancy-related Changes in Melanocytic Nevi

University Hospital Basel

Status

Completed

Conditions

Melanocytic Nevi (MN)

Treatments

Other: standard-of-care clinical skin examination

Diagnostic Test: skin assessment with the 2D FotoFinder ATBM master system

Other: data collection by participant questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT05148455

2020-02494 th21Maul2;

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.