DERM Health Economics Study

NCT04123678 | Completed

• 1 other identifier: DERM-005
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to provide an initial assessment of the potential impact DERM could have on the number of onward referrals for a face to face dermatologist review and/or biopsy from a teledermatology-based service, and to improve the understanding of the patient pathways that exist.

Conditions

Melanoma; Non-melanoma Skin Cancer

Outcome Measures

Primary Outcomes (1)

• Referral rate

  The rate of unnecessary referrals for a face to face dermatologist review for the same detection rate between standard of care and DERM of lesions reviewed by teledermatology or DERM

  Study completion, on average 5 days

Secondary Outcomes (26)

• Sensitivity of DERM on biopsied lesions

  Study completion, on average 5 days

• Specificity of DERM on biopsied lesions

  Study completion, on average 5 days

• False positive rate of DERM on biopsied lesions

  Study completion, on average 5 days

• False negative rate of DERM on biopsied lesions

  Study completion, on average 5 days

• Positive predictive value of DERM on biopsied lesions

  Study completion, on average 5 days

Study Arms (1)

All

Patients attending a Medical Photography facility with at least 1 suspicious skin lesion will be approached to participate in the study. Participants will have an additional macro and dermoscopic image of each suspicious skin lesions suitable for photography. Photographs will be taken by a healthcare professional using an iPhone XR smart phone camera with a DL1 dermoscopic lens attachment. The images will be encrypted and electronically transmitted to Skin Analytics' cloud servers for analysis by DERM. The suspected diagnosis determined by DERM will be compared with dermatologist review and histologically confirmed diagnosis, where obtained. Healthcare resource utilization information and patient satisfaction data will also be collected

Device: Deep Ensemble for the Recognition of Malignancy (DERM)

Interventions

Deep Ensemble for the Recognition of Malignancy (DERM) DEVICE

AI-based decision support tool

All

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients attending Medical Photography for imaging of at least 1 suspicious skin lesion. Patients may have been referred to the teledermatology service or for imaging for monitoring purposes from the dermatology clinic or for virtual teledermatology review.

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study,
• Male or Female, aged 18 years or above,
• Has at least one suspicious skin lesion which is being photographed as part of Standard of Care (SoC),
• In the Investigators opinion, able and willing to comply with all study requirements.

You may not qualify if:

• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Sponsors & Collaborators

• Skin Analytics Limited: lead
• Innovate UK: collaborator

Study Sites (1)

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

Location

Related Publications (1)

• Marsden H, Kemos P, Venzi M, Noy M, Maheswaran S, Francis N, Hyde C, Mullarkey D, Kalsi D, Thomas L. Accuracy of an artificial intelligence as a medical device as part of a UK-based skin cancer teledermatology service. Front Med (Lausanne). 2024 Mar 22;11:1302363. doi: 10.3389/fmed.2024.1302363. eCollection 2024.

  PMID: 38585154 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 Design

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

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 11, 2019
• Study Start: February 26, 2020
• Primary Completion: August 5, 2021
• Study Completion: August 6, 2021
• Last Updated: August 13, 2021

Record last verified: 2021-08

Locations

GB (1)