Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanocytic Nevi (MN) | Pigmented Nevus | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| data collection by participant questionnaire | Other | — | UNRESOLVED |
| skin assessment with the 2D FotoFinder ATBM master system | Diagnostic Test | — | UNRESOLVED |
| standard-of-care clinical skin examination | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- pregnant women
- interventionNames
- Other: standard-of-care clinical skin examination
- Diagnostic Test: skin assessment with the 2D FotoFinder ATBM master system
- Other: data collection by participant questionnaire
- label
- non-pregnant women (control group)
- interventionNames
- Other: standard-of-care clinical skin examination
- Diagnostic Test: skin assessment with the 2D FotoFinder ATBM master system
- Other: data collection by participant questionnaire
Primary outcomes (2)
- measure
- Change in macroscopic aspect of melanocytic nevi
- timeFrame
- 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)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available