Melanocytic Nevi (MN)NCT05148455
Pregnancy-related Changes in Melanocytic Nevi
An observational study of Melanocytic Nevi (MN), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Melanocytic Nevi (MN)
- What is being tested?
- standard-of-care clinical skin examination, skin assessment with the 2D FotoFinder ATBM master system and data collection by participant questionnaire
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jan 2021to 9 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Pregnant female participants beyond the 12th week of pregnancy
- Non-pregnant female participants
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Department of Dermatology
Basel, 4031
About this study
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
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.
Read the 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.
- Conditions
- Melanocytic Nevi (MN)
- Being tested
- standard-of-care clinical skin examination, skin assessment with the 2D FotoFinder ATBM master system, data collection by participant questionnaire
- Keywords
- skin cancer screening, total body mapping, deep learning-driven body scan, FotoFinder® ATBM master, malignant melanoma, pregnancy-related changes in melanocytic nevi
- Medical subject headings
- Nevus, Pigmented, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard-of-care clinical skin examinationOther
inspection of melanocytic nevi by dermatologist
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.
data collection by participant questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| pregnant women | Not described Receives: Other: standard-of-care clinical skin examination; Diagnostic Test: skin assessment with the 2D FotoFinder ATBM master system; Other: data collection by participant questionnaire | |
| non-pregnant women (control group) | Not described Receives: Other: standard-of-care clinical skin examination; Diagnostic Test: skin assessment with the 2D FotoFinder ATBM master system; Other: data collection by participant questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in macroscopic aspect of melanocytic nevi
Change in macroscopic aspect of melanocytic nevi
Measured: 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)
Measured: 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
Change in number of new malignant melanoma
Measured: 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
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).
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start15 Jan 2021
- Primary completion2 Jun 2021
- Study completion9 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanocytic Nevi (MN)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lara Valeska Maul, Dr. med., Principal investigator, University Hospital Basel, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148455
- Sponsor's protocol ID
- 2020-02494; th21Maul2
- Status last verified
- May 2022
- First submitted
- 24 Nov 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05148455
- Acronym / sponsor ID
- 2020-02494; th21Maul2
- Conditions
- Melanocytic Nevi (MN)
- Keywords
- skin cancer screening, total body mapping, deep learning-driven body scan, FotoFinder® ATBM master, malignant melanoma, pregnancy-related changes in melanocytic nevi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnant women | – | Other: standard-of-care clinical skin examination, Diagnostic Test: skin assessment with the 2D FotoFinder ATBM master system, Other: data collection by participant questionnaire |
| non-pregnant women (control group) | – | Other: standard-of-care clinical skin examination, Diagnostic Test: skin assessment with the 2D FotoFinder ATBM master system, Other: data collection by participant questionnaire |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Pregnant female participants beyond the 12th week of pregnancy
- Non-pregnant female participants
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard-of-care clinical skin examinationinspection of melanocytic nevi by dermatologist | Other | non-pregnant women (control group), pregnant women |
| skin assessment with the 2D FotoFinder ATBM master systemThe 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. | Diagnostic test | non-pregnant women (control group), pregnant women |
| data collection by participant questionnaireAt 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. | Other | non-pregnant women (control group), pregnant women |
Primary outcome
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
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)
2 secondary outcomes
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 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara Valeska Maul, Dr. med. principal investigator
University Hospital Basel, Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanocytic Nevi (MN), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.