Non-melanoma Skin CancerNCT04116983

DERM NMSC Validation Study

An observational study of Non-melanoma Skin Cancer, run by Skin Analytics Limited at 3 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-melanoma Skin Cancer
What is being tested?: Deep Ensemble for the Recognition of Malignancy (DERM)
Type of treatment: Medical device
How many people: 572 participants
Where: 3 sitesUnited Kingdom
Study dates: 26 Jun 2020to 16 Mar 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

Royal Free London NHS Foundation Trust
London, NW3 2QG
Royal Victoria Infirmary
Newcastle upon Tyne, NE7 7DN
Poole General Hospital
Poole, BH15 2JB

Other trials in United Kingdom

About this study

Official title: Effectiveness of an Image Analysing Algorithm (DERM) to Diagnose Non-melanoma Skin Cancer (NMSC) and Benign Skin Lesions Compared to Gold Standard Clinical and Histological Diagnosis

Read the detailed description

DERM, an Artificial Intelligence (AI)-based diagnosis support tool, has been shown to be able to accurately identify Non-melanoma skin cancers (NMSC) and other conditions from historical images of suspicious skin lesions (moles). This study aims to establish how well DERM determines the presence of these conditions in images of skin lesions collected in a clinical setting.

Suspicious skin lesions that are due to be assessed by a dermatologist and a patch of healthy skin will be photographed using three commonly available smart phone cameras with a specific lens attachment. The images will be analysed by DERM, and the results compared to the clinician's diagnosis (all lesions) and histologically-conformed diagnosis (any lesion that is biopsied).

Conditions: Non-melanoma Skin Cancer
Being tested: Deep Ensemble for the Recognition of Malignancy (DERM)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Deep Ensemble for the Recognition of Malignancy (DERM)Device
An AI-based diagnosis support tool

Study groups in NCT04116983
Study group	Role	What they receive
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. Receives: Device: Deep Ensemble for the Recognition of Malignancy (DERM)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Study completion

Secondary outcomes (17)

AUROC of DERM performance when analysing images of non-biopsied lesions
Area Under the Receiver Operating Characteristic Curve (AUROC) of the DERM result of biopsied lesions, using clinical diagnosis as gold standard
Measured: Study completion: on average 2 days
The sensitivity of DERM when used to assess biopsied lesions
The sensitivity of DERM when used to assess biopsied lesions
Measured: Study completion: on average 2 days
The specificity of DERM when used to assess biopsied lesions
The specificity of DERM when used to assess biopsied lesions
Measured: Study completion: on average 2 days
The false positive rate of DERM when used to assess biopsied lesions
The false positive rate of DERM when used to assess biopsied lesions
Measured: Study completion: on average 2 days
The false negative rate of DERM when used to assess biopsied lesions
The false negative rate of DERM when used to assess biopsied lesions
Measured: Study completion: on average 2 days
The positive predictive value of DERM when used to assess biopsied lesions
The positive predictive value of DERM when used to assess biopsied lesions
Measured: Study completion: on average 2 days
The negative predictive value of DERM when used to assess biopsied lesions
The negative predictive value of DERM when used to assess biopsied lesions
Measured: Study completion: on average 2 days
The sensitivity of DERM when used to assess non-biopsied lesions
The sensitivity of DERM when used to assess non-biopsied lesions
Measured: Study completion: on average 2 days
The specificity of DERM when used to assess non-biopsied lesions
The specificity of DERM when used to assess non-biopsied lesions
Measured: Study completion: on average 2 days
The false positive rate of DERM when used to assess non-biopsied lesions
The false positive rate of DERM when used to assess non-biopsied lesions
Measured: Study completion: on average 2 days
The false negative rate of DERM when used to assess non-biopsied lesions
The false negative rate of DERM when used to assess non-biopsied lesions
Measured: Study completion: on average 2 days
The positive predictive value of DERM when used to assess non-biopsied lesions
The positive predictive value of DERM when used to assess non-biopsied lesions
Measured: Study completion: on average 2 days
The negative predictive value of DERM when used to assess non-biopsied lesions
The negative predictive value of DERM when used to assess non-biopsied lesions
Measured: Study completion: on average 2 days
Concordance of clinician assessment with histologically confirmed diagnosis
Concordance of clinician assessment with histologically confirmed diagnosis
Measured: Study completion: on average 2 days
The concordance of DERM result generated using images from each camera
The concordance of DERM result generated using images from each camera
Measured: Study completion: on average 2 days
The proportion of skin lesions with 3 images that can be analysed by DERM;
The proportion of skin lesions with 3 images that can be analysed by DERM;
Measured: Study completion: on average 2 days
The proportion of skin lesions with at least 1 readable image that can be analysed by DERM
The proportion of skin lesions with at least 1 readable image that can be analysed by DERM
Measured: Study completion: on average 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 202016 Mar 2022

First posted7 Oct 2019
Study start26 Jun 2020
Primary completion28 Feb 2022
Study completion16 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-melanoma Skin CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 572 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04116983
Sponsor's protocol ID: DERM-003
Status last verified: May 2022
First submitted: 30 Sep 2019
Last updated: 18 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Research to improve or test the performance of DERM only allowed in consent

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 2
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RecruitingPhase 4
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All Non-melanoma Skin Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of an Image Analysing Algorithm (DERM) to Diagnose Non-melanoma Skin Cancer (NMSC) and Benign Skin Lesions Compared to Gold Standard Clinical and Histological Diagnosis
ClinicalTrials.gov ID: NCT04116983
Acronym / sponsor ID: DERM-003
Conditions: Non-melanoma Skin Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 572 participants (actual)
Lead sponsor: Skin Analytics LimitedIndustry (pharma, biotech, devices)
Collaborators: Innovate UK
Study start: 26 Jun 2020 (actual)
Primary completion: 28 Feb 2022 (actual)
Study completion: 16 Mar 2022 (actual)
First posted: 7 Oct 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All patients	–	Device: Deep Ensemble for the Recognition of Malignancy (DERM)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients attending a dermatology clinic with at least 1 suspicious skin lesion

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Deep Ensemble for the Recognition of Malignancy (DERM)An AI-based diagnosis support tool	Device	All patients

Primary outcome

AUROC of DERM performance when analysing images of biopsied lesions
Time frame: Study completion
Area Under the Receiver Operating Characteristic Curve (AUROC) of the DERM result of biopsied lesions, using histopathological-confirmed diagnosis as gold standard

17 secondary outcomes

AUROC of DERM performance when analysing images of non-biopsied lesions
Time frame: Study completion: on average 2 days
The sensitivity of DERM when used to assess biopsied lesions
Time frame: Study completion: on average 2 days
The specificity of DERM when used to assess biopsied lesions
Time frame: Study completion: on average 2 days
The false positive rate of DERM when used to assess biopsied lesions
Time frame: Study completion: on average 2 days
The false negative rate of DERM when used to assess biopsied lesions
Time frame: Study completion: on average 2 days
The positive predictive value of DERM when used to assess biopsied lesions
Time frame: Study completion: on average 2 days
The negative predictive value of DERM when used to assess biopsied lesions
Time frame: Study completion: on average 2 days
The sensitivity of DERM when used to assess non-biopsied lesions
Time frame: Study completion: on average 2 days
The specificity of DERM when used to assess non-biopsied lesions
Time frame: Study completion: on average 2 days
The false positive rate of DERM when used to assess non-biopsied lesions
Time frame: Study completion: on average 2 days
The false negative rate of DERM when used to assess non-biopsied lesions
Time frame: Study completion: on average 2 days
The positive predictive value of DERM when used to assess non-biopsied lesions
Time frame: Study completion: on average 2 days
The negative predictive value of DERM when used to assess non-biopsied lesions
Time frame: Study completion: on average 2 days
Concordance of clinician assessment with histologically confirmed diagnosis
Time frame: Study completion: on average 2 days
The concordance of DERM result generated using images from each camera
Time frame: Study completion: on average 2 days
The proportion of skin lesions with 3 images that can be analysed by DERM;
Time frame: Study completion: on average 2 days
The proportion of skin lesions with at least 1 readable image that can be analysed by DERM
Time frame: Study completion: on average 2 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
Individual participant dataSharing planned: Undecided. Research to improve or test the performance of DERM only allowed in consent

Related trials for Non-melanoma Skin Cancer

Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingObservational study
Predicting Response to Anti-PD-1/PD-L1 Immunotherapy by Plasma Extracellular Vesicle Analysis
Non-Small Cell Lung Cancer, Melanoma (Skin Cancer)
RecruitingPhase 2
A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
Advanced Solid Tumor, Melanoma
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 4
Dabrafenib and/or Trametinib Rollover Study
Melanoma, Non Small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Non-melanoma Skin Cancer, run by Skin Analytics Limited at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUROC of DERM performance when analysing images of biopsied lesions (time frame: Study completion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04116983.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022; AzTrials last refreshed its copy on 26 Oct 2026.