DERM NMSC Validation Study

NCT04116983 | Completed

• 1 other identifier: DERM-003
• Study Type: observational
• Target: 572
• Locations: 1 country
• Sites: 3

Brief Summary

This study aims to establish the effectiveness of an Artificial Intelligence (AI) algorithm (DERM) to determine the presence of Basal Cell Carcinoma (BCC) and Squamous Cell Carcinoma (SCC) and frequently observed benign conditions, when used to analyse images of skin lesions taken by commonly available smart phone cameras.

Conditions

Non-melanoma Skin Cancer

Outcome Measures

Primary Outcomes (1)

• AUROC of DERM performance when analysing images of biopsied lesions

  Area Under the Receiver Operating Characteristic Curve (AUROC) of the DERM result of biopsied lesions, using histopathological-confirmed diagnosis as gold standard

  Study completion

Secondary Outcomes (17)

• AUROC of DERM performance when analysing images of non-biopsied lesions

  Study completion: on average 2 days

• The sensitivity of DERM when used to assess biopsied lesions

  Study completion: on average 2 days

• The specificity of DERM when used to assess biopsied lesions

  Study completion: on average 2 days

• The false positive rate of DERM when used to assess biopsied lesions

  Study completion: on average 2 days

• The false negative rate of DERM when used to assess biopsied lesions

  Study completion: on average 2 days

Other Outcomes (4)

• Impact of patient characteristics on the DERM and clinician assessment

  Study completion: on average 2 days

• Impact of lesion characteristics on the DERM and clinician assessment

  Study completion: on average 2 days

• The impact of image variables on the diagnostic accuracy of DERM assessment

  Study completion: on average 2 days

Study Arms (1)

All patients

Recruited participants will be attending a dermatology clinic with at least one skin lesion where there is a suspicion of skin cancer. All suspicious lesions suitable for photographing will be photographed six times in a single visit. A macro and dermoscopic image of each lesion will be captured by three different mobile phones: an iPhone, a Samsung and a Nokia smart phone, without (macro image) or with (dermoscopic image) a Dermlite DL1 lens attached. Dermoscopic images of healthy skin will also be captured by each camera. Images of the lesions will be analysed by DERM. The DERM results for lesions biopsied will be compared to the biopsy result; the DERM results for lesions not biopsied will be compared to the clinical assessment.

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

Interventions

Deep Ensemble for the Recognition of Malignancy (DERM) DEVICE

An AI-based diagnosis support tool

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending a dermatology clinic with at least 1 suspicious skin lesion

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,
• Have at least suspicious skin lesion which is suitable for photographing (\<15mm, not located on an anatomical site inappropriate to photograph (genitalia, hair-bearing areas, under nails), not previously biopsied, not located in an area of visible scarring or tattooing),
• In the Investigator's 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 participant 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 (3)

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Poole General Hospital

Poole, BH15 2JB, United Kingdom

Location

Study Design

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

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 7, 2019
• Study Start: June 26, 2020
• Primary Completion: February 28, 2022
• Study Completion: March 16, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

GB (3)