Melanoma Detection in Switzerland With VECTRA

NCT04605822 | Completed

• 1 other identifier: 2020-02482; sp20Maul
• Study Type: observational
• Target: 455
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (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®

Outcome Measures

Primary Outcomes (5)

• 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).

  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 (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.

  up to 24 months

• 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).

  up to 24 months

• 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).

  up to 24 months

• 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).

  up to 12 months

Secondary Outcomes (6)

• Change in Distress thermometer (Patient-reported outcome)

  up to 24 months

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

  up to 24 months

• Change in Hospital Anxiety and Depression Scale (HADS)

  up to 24 months

• Change in Melanoma Worry Scale (MWS)

  up to 24 months

• Change in support need and uptake

  up to 24 months

Other Outcomes (4)

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

  Up to 3 years

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

  Up to 3 years

• Patient perception of AI utilisation in skin cancer screening via questionaire

  Up to 3 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Dermatology, University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 38411348 DERIVED

• 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.

  PMID: 38158385 DERIVED

• 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.

  PMID: 37453242 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Lara Valeska Maul, Dr. med.

  Department of Dermatology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 28, 2020
• Study Start: January 25, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

CH (1)