Pregnancy-related Changes in Melanocytic Nevi

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

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 Overview

• Status: Completed
• Conditions: Melanocytic Nevi (MN)
• Intervention / Treatment: Other: standard-of-care clinical skin examination; Diagnostic test: skin assessment with the 2D FotoFinder ATBM master system; Other: data collection by participant questionnaire

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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Lara Valeska Maul, Dr. med., University Hospital Basel, Department of Dermatology

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): June 2, 2021
• Study Completion (Actual): February 9, 2022

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 8, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: malignant melanoma; skin cancer screening; total body mapping; deep learning-driven body scan; FotoFinder® ATBM master; pregnancy-related changes in melanocytic nevi
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Nevi and Melanomas; Nevus, Spindle Cell; Nevus; Nevus, Pigmented; Nevus, Epithelioid and Spindle Cell
• Other Study ID Numbers: 2020-02494; th21Maul2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No