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Pregnancy-related Changes in Melanocytic Nevi

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ClinicalTrials.gov Identifier: NCT05148455
Recruitment Status : Completed
First Posted : December 8, 2021
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment
Melanocytic Nevi (MN) 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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 15, 2021
Actual Primary Completion Date : June 2, 2021
Actual Study Completion Date : February 9, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05148455


Locations
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Switzerland
University Hospital Basel, Department of Dermatology
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Lara Valeska Maul, Dr. med. University Hospital Basel, Department of Dermatology
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT05148455    
Other Study ID Numbers: 2020-02494; th21Maul2
First Posted: December 8, 2021    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
skin cancer screening
total body mapping
deep learning-driven body scan
FotoFinder® ATBM master
malignant melanoma
pregnancy-related changes in melanocytic nevi
Additional relevant MeSH terms:
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Nevus
Nevus, Pigmented
Nevus, Epithelioid and Spindle Cell
Nevi and Melanomas
Neoplasms by Histologic Type
Neoplasms
Nevus, Spindle Cell