A study to assess whether an Artificial Intelligence (AI) technology can be used to assess images of suspicious skin lesions to determine the likelihood of skin cancer; and reduce the number, and cost assocated with, biopsies of skin lesions in primary care

Assessing the effectiveness of an Artificial Intelligence (AI) algorithm to identify skin cancer lesions: The Deep Ensemble for Recognition of Malignancy (DERM) in Primary Care Study

Status

Terminated

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000398101

Enrollment

Registered

2019-03-12

Start date

2022-02-25

Completion date

2022-11-30

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to investigate the impact of an Artificial Intelligence (AI) algorithm - Deep Ensemble for Recognition of Malignancy (DERM) - on skin cancer diagnosis services in primary care. Who is it for? You may be eligible for this study if you are over the age of 40 and are visiting your GP with at least one suspicious skin lesion that is suitable for photographing. Study details All participants in this study will have a photograph taken of their suspicious lesion(s) during their regular GP consult, which DERM will analyse. The GP will decide whether to biopsy the lesion before DERM provides a recommendation on whether the lesion should be tested further. Where DERM recommends a lesion is biopsied that the GP otherwise would not have done, the GP may choose to follow DERMs recommendation or their own assessment. It is hoped that this research will help determine if DERM can help identify cancerous skin lesions and reduce the number of unnecessary biopsies.

Interventions

All participants will have their suspect skin lesion(s) photographed on a smartphone camera with a dermosopic lens attachment by their General Practitioner (GP). The process should take 2-3 minutes of their standard GP visit. The GP will decide whether to biopsy each lesion. The images will then be analysed by an Artificial Intelligence (AI)-based tool, Deep Ensemble for Recognition of Malignancy (DERM) in real time, and immediately (within 1 minute) return a response to the GP. Where the GP has decided to biopsy the lesion, the response will be for the GP to continue as planned. Where the GP decided not to biopsy a lesions, but DERM recommends this, the GP may decide to change the patient management plan. The final decision on whether to biopsy each lesion is made by the GP (in agreement with the patient).

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Adult patients (18 years or older) who attend a primary care practice and have a clinical assessment of at least one suspicious skin lesion that is suitable for photographing (<15mm, in an anatomical site unsuitable for photographing, has previously been biopsied or in an area of visible scarring).

Exclusion criteria

None

Outcome results