Skip to main content
OpenTrials
Completed

NCT Number: NCT05148455

Pregnancy-related Changes in Melanocytic Nevi

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Melanocytic Nevi (MN) Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Nevus Nevus, Pigmented Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Basel, Department of Dermatology

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

standard-of-care clinical skin examination

Other

inspection of melanocytic nevi by dermatologist

skin assessment with the 2D FotoFinder ATBM master system

Diagnostic 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.

data collection by participant questionnaire

Other

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.

Primary outcomes

  1. Change in macroscopic aspect of melanocytic nevi

    Time frame: 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 macroscopic aspect of melanocytic nevi

  2. Change in mole analyzer score with the 2D FotoFinder ATBM master system

    Time frame: 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)

    mole analyzer score (0.0-1.0; 0 indicating no suspicion for melanoma, 1 indicating a high suspicion for melanoma)

Secondary outcomes

  1. Change in number of new malignant melanoma

    Time frame: 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 number of new malignant melanoma

  2. Change in psychological impact of skin cancer screening by descriptive analyzes of participants questionnaire

    Time frame: 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 (investigating the subjective examination experience, the impact on skin cancer worries and the participants' sun protection and self-inspection behaviour).

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 8, 2021
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.