Clinical trial NCT05148455: Pregnancy-related Changes in Melanocytic Nevi
Official title: Total Body Dermoscopic Evaluation of Pregnancy-related Changes in Melanocytic Nevi Using the FotoFinder ATBM Master System and the Impact of Artificial Intelligence Assisted Examinations on the Patients' Skin Cancer Screening Experience: A Prospective Two-arm Controlled Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanocytic Nevi (MN)
Keywords: skin cancer screening
total body mapping
deep learning-driven body scan
FotoFinder® ATBM master
malignant melanoma
pregnancy-related changes in melanocytic nevi
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-12-08
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in macroscopic aspect of melanocytic nevi
timeFrame: 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: Change in mole analyzer score with the 2D FotoFinder ATBM master system
timeFrame: 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)
Secondary outcomes:
measure: Change in number of new malignant melanoma
timeFrame: 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: Change in psychological impact of skin cancer screening by descriptive analyzes of participants questionnaire
timeFrame: 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)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Dermatology
Study officials:
affiliation: University Hospital Basel, Department of Dermatology
name: Lara Valeska Maul, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: