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How Consistent is the Output of DERM, When Used to Assess Images of Potentially Cancerous Skin Lesions.

NCT06654999 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 115

Last updated 2025-07-09

No results posted yet for this study

Summary

DERM is a Medical Device that uses artificial intelligence to help doctors check if a skin lesion might be cancerous. It works by analysing close-up pictures of skin lesions taken with a smartphone.

This study aims to demonstrate how consistent (precise) the output of DERM is: i.e. does it provide the same result when it analyses multiple photos of the same lesion (repeatability), and when the same lesion is photographed by different people, or with different cameras (reproducibility).

Adults with at least one skin lesion that doctors are checking for cancer, as part of their standard care, will be able to take part. Suitable lesions will be photographed three times, each by three different people using three sets of image capture hardware (specifically, an iPhone 11 with a DL200/HR dermoscopic lens). Each image will be checked for good image quality as it is captured. Images will then be transferred to DERM, where they'll be analysed.

The DERM output won't be shared with the patients or doctors involved in the study. The patients will continue to have their skin lesion biopsy/excised, in accordance with standard of care. Their diagnosis will be collected and compared to the output from DERM.

Conditions

  • Skin Cancer
  • Melanoma of Skin
  • Squamous Cell Cancer
  • Basal Cell Cancer

Interventions

DEVICE

Deep Ensemble for the Recognition of Malignancy (DERM)

DERM variants "+" and "DS"

Sponsors & Collaborators

  • Skin Analytics Limited

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-18
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06654999 on ClinicalTrials.gov