We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Melanoma Detection in Switzerland With VECTRA (MELVEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04605822
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : April 12, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment
Melanoma (Skin) Device: 3D imaging Total Body Photography Vectra® WB360 Device: 2D imaging FotoFinder ATBM® Master imaging system Device: Smartphone application (SkinVision®) Other: Standard-of-care clinical assessment of the skin

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 720 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 25, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: 3D imaging Total Body Photography Vectra® WB360
    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.
  • Device: 2D imaging FotoFinder ATBM® Master imaging system
    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.
  • Device: Smartphone application (SkinVision®)
    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.
  • Other: Standard-of-care clinical assessment of the skin
    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.

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04605822


Contacts
Layout table for location contacts
Contact: Lara Valeska Maul, Dr. med. : +41 61 265 4080 laravaleska.maul@usb.ch

Locations
Layout table for location information
Switzerland
Department of Dermatology, University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Lara Valeska Maul, Dr. med.    +41 61 265 4080    laravaleska.maul@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Layout table for investigator information
Principal Investigator: Lara Valeska Maul, Dr. med. Department of Dermatology, University Hospital Basel
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT04605822    
Other Study ID Numbers: 2020-02482; sp20Maul
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: April 12, 2022
Last Verified: April 2022

Layout table for additional information
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:
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®
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas