Conditions

Keywords

skin cancer screeningtotal body mappingdeep learning-driven body scanFotoFinder® ATBM mastermalignant melanomapregnancy-related changes in melanocytic nevi

Outcome Measures

Primary Outcomes (2)

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 Outcomes (2)

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
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)

Study Arms (2)

pregnant women

Other: standard-of-care clinical skin examinationDiagnostic Test: skin assessment with the 2D FotoFinder ATBM master systemOther: data collection by participant questionnaire

non-pregnant women (control group)

Other: standard-of-care clinical skin examinationDiagnostic Test: skin assessment with the 2D FotoFinder ATBM master systemOther: data collection by participant questionnaire

Interventions

standard-of-care clinical skin examinationOther

inspection of melanocytic nevi by dermatologist

non-pregnant women (control group)pregnant women

skin assessment with the 2D FotoFinder ATBM master systemDiagnostic 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.

Eligibility Criteria

Age18 Years - 40 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodProbability 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.

You may qualify if:

Sponsors & Collaborators

University Hospital, Basel, Switzerland
Otherlead

Study Sites (1)

University Hospital Basel, Department of Dermatology

Basel, 4031, Switzerland

MeSH Terms

Conditions

Nevus, PigmentedMelanoma

Condition Hierarchy (Ancestors)

NevusNevi and MelanomasNeoplasms by Histologic TypeNeoplasmsNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Lara Valeska Maul, Dr. med.
University Hospital Basel, Department of Dermatology
PRINCIPAL INVESTIGATOR

Pregnancy-related Changes in Melanocytic Nevi

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

pregnant women

non-pregnant women (control group)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

pregnant women

non-pregnant women (control group)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations