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Pregnancy-related Changes in Melanocytic Nevi

NCT05148455 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2022-05-18

No results posted yet for this study

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.

Conditions

  • Melanocytic Nevi (MN)

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Lara Valeska Maul, Dr. med. · University Hospital Basel, Department of Dermatology

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2021-06-02
Completion
2022-02-09

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05148455 on ClinicalTrials.gov