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Completed

NCT Number: NCT04605822

Melanoma Detection in Switzerland With VECTRA

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Dermatology, University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

3D imaging Total Body Photography Vectra® WB360

Device

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 system

Device

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 skin

Other

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.

Primary outcomes

  1. Analyses of histopathology reports of all excised suspectable lesions

    Time frame: up to 24 months

    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).

  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

    Time frame: up to 24 months

    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.

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

    Time frame: up to 24 months

    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).

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

    Time frame: up to 24 months

    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).

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

    Time frame: up to 12 months

    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).

Secondary outcomes

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

    Time frame: up to 24 months

    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.

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

    Time frame: up to 24 months

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

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

    Time frame: up to 24 months

    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

  4. Change in Melanoma Worry Scale (MWS)

    Time frame: up to 24 months

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

  5. Change in support need and uptake

    Time frame: up to 24 months

    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).

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

    Time frame: up to 24 months

    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.

Other outcomes

  1. Comparison of automated naevus counts from 3D total-body photography

    Time frame: Up to 3 years

    Comparison of automated naevus counts from 3D total-body photography generated by collegues in Australia

  2. Impact of sun damage on diagnostic accuracy of DEXI algorithm in melanoma recognition

    Time frame: Up to 3 years

    Determination of the impact of sun damage on diagnostic accuracy of DEXI algorithm in melanoma recognition

  3. Patient perception of AI utilisation in skin cancer screening via questionaire

    Time frame: Up to 3 years

    Including willingness to pay for 3D TBP

  4. Comparison of the diagnostic accuracy of different algorithms by using ROC-AUC curves

    Time frame: Up to 3 years

    Investigating how different algorithms might change diagnostic accuracy

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Acronym: MELVEC

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2020
Registry last updated
Mar 19, 2024

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.

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