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Melanoma (Skin)MELVECNCT04605822

Melanoma Detection in Switzerland With VECTRA

An observational study of Melanoma (Skin), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is to compare 2D- and 3D-imaging and routine clinical care in early melanoma detection in a prospective large-scale real-world data set. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin)
What is being tested?
3D imaging Total Body Photography Vectra® WB360, 2D imaging FotoFinder ATBM® Master imaging system and Smartphone application (SkinVision®)
Type of treatment
Medical device
How many people
455 participants
Where
1 siteSwitzerland
Study dates
25 Jan 2021to 31 Jan 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients will be recruited during melanoma consultations and the consultation in the outpatient clinic at the Department of Dermatology at the University Hospital Basel from Q4/2020 until Q4/2021.

Who may be able to join

  • Written informed consent of the patient
  • Sufficient fluency in German language skills to complete all questionnaires of the study without external assistance
  • High-risk criteria for melanoma. For "high risk" one of the following criteria needs to be fulfilled:
  • At least one previous melanoma (including melanoma in situ)
  • A diagnosis of ≥ 100 nevi
  • A diagnosis of ≥ 5 atypical nevi
  • A diagnosis of dysplastic nevus syndrome or known CDKN2A mutation
  • A strong family history (≥ 1 first- and/or second-degree relatives)

Who cannot join

  • Lack of informed consent for study participation.
  • Fitzpatrick skin type V-VI.
  • Acute psychiatric illness or acute crisis

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Department of Dermatology, University Hospital Basel

    Basel, 4031

Other trials in Switzerland

About this study

Official title: Clinical Performance of the New Artificial-intelligence Powered 3D Total Body Photography System VECTRA® in Early Melanoma Detection and Its Impact on Patients' Burden of Disease: A Prospective Cohort Study in a Real-world Setting

This study is to compare 2D- and 3D-imaging and routine clinical care in early melanoma detection in a prospective large-scale real-world data set.

Read the detailed description

This study is to compare the accuracy of combining human and artificial intelligence with its independent application in early melanoma detection. The Artificial Intelligence (AI)-powered 3D Total Body Photography (TBP) Vectra® WB360 system's utility and clinical performance in detecting melanoma in the real-world setting will be compared to the gold standard with clinical assessments by experienced dermatologists, to currently widespread used 2D imaging tools (FotoFinder ATBM® Master) and to the Smartphone-based algorithm application (e.g. SkinVision®). Here included are specific questions regarding the patients' subjective experience, acceptance and evaluation of modern technological examination.

Additionally, the overall psychological burden and worry of melanoma risk or disease, anxiety, depression will be compared in different groups of patients and psychological support need and real uptake of support and its predictors will be investigated in all participants.

To validate the MELVEC (Melanoma Detection in Switzerland with Vectra®) test procedure, an analysis of the measurement repeatability of computer-guided risk assessment scores for early melanoma detection will be performed. A potential benefit of this validation analysis is the optimization of study procedure for future follow-up visits and further enrolled patients in the MELVEC study. Additionally, results will shed light on the reliability of the convolutional neural networks (CNNs) investigated and help formulate recommendations for their current use. Furthermore, results will provide important data for the manufacturers regarding the systems' reliability in clinical application to help future improvement of the respective algorithms.

Conditions
Melanoma (Skin)
Being tested
3D imaging Total Body Photography Vectra® WB360, 2D imaging FotoFinder ATBM® Master imaging system, Smartphone application (SkinVision®), Standard-of-care clinical assessment of the skin
Keywords
3D total body photography (TBP), 2D sequential digital dermatoscopic imaging (SDDI), skin malignancy, artificial intelligence (AI)- based tools, 3D TBP Vectra® WB360 system, FotoFinder ATBM® Master, SkinVision®
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D imaging Total Body Photography Vectra® WB360Device

    3D Total Body Photography Vectra® WB360 (Canfield Scientific, Parsippany, New Jersey, USA) and its digital dermoscopic camera (VISIOMED® D200evo dermatoscope) and scoring of pigmented skin lesions. All participants of this study will undergo 3D TBP at baseline and the follow-up visits up to month 24.

  • 2D imaging FotoFinder ATBM® Master imaging systemDevice

    2D imaging with FotoFinder® Mole Analyzer and scoring of pigmented skin lesions. All participants of this study will undergo 2D imaging FotoFinder ATBM® Master imaging system at baseline and the follow-up visits up to month 24.

  • Smartphone application (SkinVision®)Device

    Smartphone application for all dermatoscopically documented pigmented skin lesions in all study participations and record of risk assessment of the health application (low, medium or high risk) to compare the app's accuracy in risk assessment with the AI tools and the dermatologist. The SkinVision® smartphone app is CE certified.of skin lesions. All participants of this study will undergo Smartphone application (SkinVision®) at baseline and the follow-up visits up to month 12.

  • Standard-of-care clinical assessment of the skinOther

    Clinical skin examination with dermatoscope by an experienced dermatologist and risk assessment of pigmented lesions (melanoma vs. naevus). All participants of this study will undergo Standard-of-care clinical assessment of the skin at baseline and the follow-up visits up to month 24.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Analyses of histopathology reports of all excised suspectable lesions

    The primary outcome, the sensitivity of human and artificial intelligence in detecting melanoma, will be measured at every study visit in case of a suspected melanoma by analysing histopathology reports of all excised suspectable lesions. The diagnosis of melanoma will be confirmed by histology. The biopsied pigmented skin lesions will be categorized as benign (melanocytic nevi / dysplastic nevi) or malignant (melanoma).

    Measured: up to 24 months

  2. Analyses of dermatologists' assessment of each pigmented skin lesion as benign (melanocytic nevi / dysplastic nevi) or malignant (melanoma) before and after (without and with knowledge of) computer-guided risk assessment scores

    Analyses of dermatologists' assessment of each pigmented skin lesion as benign (melanocytic nevi / dysplastic nevi) or malignant (melanoma) before and after computer-guided risk assessment scores by Vectra® WB360 and FotoFinder® Mole Analyzer and smartphone app.

    Measured: up to 24 months

  3. Analyses of 2D FotoFinder® Mole Analyzer scoring of pigmented skin lesions (0.0 - 1.0)

    The primary outcome, the sensitivity of human and artificial intelligence in detecting melanoma, will be measured at every study visit in case of a suspected melanoma by 2D FotoFinder® Mole Analyzer scoring of pigmented skin lesions (0.0 - 1.0). Scores 0.0 - 1.0; 0 indicating no suspicion for melanoma, 1 indicating a high suspicion for melanoma).

    Measured: up to 24 months

  4. Analyses of 3D Vectra® WB360 imaging scoring of pigmented skin lesions (0- 10)

    The primary outcome, the sensitivity of human and artificial intelligence in detecting melanoma, will be measured at every study visit in case of a suspected melanoma by analysing 3D Vectra® WB360 imaging scoring of pigmented skin lesions (0- 10). Score 0 - 10; 0 indicating no suspicion for melanoma, 10 indicating a high suspicion for melanoma).

    Measured: up to 24 months

  5. Analyses of Smartphone app Skin Vision® scoring of pigmented skin lesions (low, medium or high risk)

    The primary outcome, the sensitivity of human and artificial intelligence in detecting melanoma, will be measured at every study visit in case of a suspected melanoma by analysing Smartphone app Skin Vision® scoring of pigmented skin lesions (low, medium or high risk).

    Measured: up to 12 months

Secondary outcomes (6)

  1. Change in Distress thermometer (Patient-reported outcome)

    Distress thermometer on a scale from 0-10 to address psychological distress: German version of the NCCN Distress Thermometer is used with Problem List (PL) as the screening tool for self-reported psychosocial distress, and to identify the causes of expressed distress.

    Measured: up to 24 months

  2. Change in FACIT G7 Functional Assessment of Cancer Therapy - General - (7 item version).

    The FACIT Measurement System is a collection of QOL questionnaires targeted to the management of chronic illness.

    Measured: up to 24 months

  3. Change in Hospital Anxiety and Depression Scale (HADS)

    The HADS is a 14-item self-administered questionnaire widely used to detect anxiety and depression in physically ill patients and is validated for the German language. The questionnaire has two subscales (anxiety and depression) with seven items each and a total score for each subscale (values from 0-21). Subscale scores between 0-7 indicate normal anxiety and depression levels, scores between 8-10 indicate borderline levels of anxiety and depression, and scores between 11-21 indicate clinical levels of anxiety or depression

    Measured: up to 24 months

  4. Change in Melanoma Worry Scale (MWS)

    MWS comprises four items, score 1 to 4, with possible scores ranging from 4 to 17, a higher score indicating higher levels of worry

    Measured: up to 24 months

  5. Change in support need and uptake

    Support need and uptake will be collected by questions regarding participants' prospective intention to use psycho-oncological support services ("Do you intend to use the in-house psycho-oncological support service in the next months?", answer options: yes, maybe, no), the recommendation by the dermatologist for psychological support as well as patients' real uptake (hospital record).

    Measured: up to 24 months

  6. Patients' subjective experience and evaluation of modern technological examination

    Study specific questions concerning the individuals' perceptions focusing the benefits by potentially improved sensitivity and specificity and possible disadvantages of the additional technology (3D TBP) in melanoma screening will be asked. The psychological impact of 3D TBP usage in melanoma screening and its effect on patients' cancer worry will be evaluated.

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2020
  2. Study start25 Jan 2021
  3. Primary completion31 Jan 2024
  4. Study completion31 Jan 2024

Resources

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
455 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04605822
Sponsor's protocol ID
2020-02482; sp20Maul
Acronym
MELVEC
Status last verified
Mar 2024
First submitted
21 Oct 2020
Last updated
19 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Goessinger EV, Niederfeilner JC, Cerminara S, Maul JT, Kostner L, Kunz M, Huber S, Koral E, Habermacher L, Sabato G, Tadic A, Zimmermann C, Navarini A, Maul LV. Patient and dermatologists' perspectives on augmented intelligence for melanoma screening: A prospective study. J Eur Acad Dermatol Venereol. 2024 Dec;38(12):2240-2249. doi: 10.1111/jdv.19905. Epub 2024 Feb 27.

    PubMed 38411348

  • Goessinger EV, Cerminara SE, Mueller AM, Gottfrois P, Huber S, Amaral M, Wenz F, Kostner L, Weiss L, Kunz M, Maul JT, Wespi S, Broman E, Kaufmann S, Patpanathapillai V, Treyer I, Navarini AA, Maul LV. Consistency of convolutional neural networks in dermoscopic melanoma recognition: A prospective real-world study about the pitfalls of augmented intelligence. J Eur Acad Dermatol Venereol. 2024 May;38(5):945-953. doi: 10.1111/jdv.19777. Epub 2023 Dec 29.

    PubMed 38158385

  • Cerminara SE, Cheng P, Kostner L, Huber S, Kunz M, Maul JT, Bohm JS, Dettwiler CF, Geser A, Jakopovic C, Stoffel LM, Peter JK, Levesque M, Navarini AA, Maul LV. Diagnostic performance of augmented intelligence with 2D and 3D total body photography and convolutional neural networks in a high-risk population for melanoma under real-world conditions: A new era of skin cancer screening? Eur J Cancer. 2023 Sep;190:112954. doi: 10.1016/j.ejca.2023.112954. Epub 2023 Jun 24.

    PubMed 37453242

Questions about this trial

What is this clinical trial studying?

An observational study of Melanoma (Skin), 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 8 inclusion and 3 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 19 Mar 2024. 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?

Analyses of histopathology reports of all excised suspectable lesions (time frame: up to 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04605822, which also lists 3 linked publications.

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 19 Mar 2024.

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