Skin CancerNCT06654999
How Consistent is the Output of DERM, When Used to Assess Images of Potentially Cancerous Skin Lesions.
An observational study of Skin Cancer and Melanoma of Skin, run by Skin Analytics Limited at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Cancer, Melanoma of Skin, Squamous Cell Cancer
- What is being tested?
- Deep Ensemble for the Recognition of Malignancy (DERM)
- Type of treatment
- Medical device
- How many people
- 115 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 18 Dec 2024to 30 Jun 2025
- 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 will be recruited in specialist dermatology clinics in the UK.
Who may be able to join
- Male or Female,
- aged 18 years or above,
- Willing and able to give informed consent for participation in the study,
- Has at least one skin lesion that, following assessment by a primary care provider and a dermatology specialist, will be biopsied due to a high suspicion of skin cancer, and is suitable for assessment by DERM.
- In the Investigator's opinion, able and willing to comply with all study requirements.
Who cannot join
- Patients with more than one skin lesion due for biopsy
- 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.
- To be suitable for inclusion, a skin lesion must NOT have ANY of the following limitations:
- Be located on an anatomical site of different skin structure: palms of hands or soles of feet (acral lesion), mucosal surfaces (lips and eyes) or under nail (ungal lesion),
- Have a diameter greater than the diameter of the dermoscopic lens,
- Be located on an anatomical site unsuitable for photographing, including on surface of genitals and hair-bearing areas,
- Have been previously biopsied, excised, treated or is otherwise traumatised
- Be located in an area of visible scarring or tattooing.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Norwich and Norfolk Hospitals Trust
Norwich
University Hospitals Dorset
Poole
Surrey and Sussex Hospital Trust
Redhill
About this study
Official title: A Precision Study To Demonstrate The Repeatability and Reproducability of DERM Outputs
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).
Read more
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
- Being tested
- Deep Ensemble for the Recognition of Malignancy (DERM)
- Keywords
- Precision, DERM, Repeatability, Reproducability
- Medical subject headings
- Skin Neoplasms, Melanoma, Neoplasms, Squamous Cell, Neoplasms, Basal Cell
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
DERM variants "+" and "DS"
| Study group | Role | What they receive |
|---|---|---|
| All patients | All patients will have their skin lesion imaged in the same way 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.
Reproducibility: Average Positive Agreement (APA) of DERM on malignant lesions is >80%
Each lesion will be imaged by three users using three sets of the image capture hardware, generating nine data sets (user/hardware combinations) per lesion. Each lesion image data set will consist of 3 repeated measures, resulting in 27 measures per lesion
Measured: 1 day
Repeatability: Average Positive Agreement (APA) of DERM on malignant lesions is >80%
Each lesion will be imaged by three users using three sets of the image capture hardware, generating nine data sets (user/hardware combinations) per lesion. Each lesion image data set will consist of 3 repeated measures, resulting in 27 measures per lesion.
Measured: 1 day
Secondary outcomes (2)
Reproducibility: Average Negative Agreement (ANA) of DERM on benign lesions is >50%
Each lesion will be imaged by three users using three sets of the image capture hardware, generating nine data sets (user/hardware combinations) per lesion. Each lesion image data set will consist of 3 repeated measures, resulting in 27 measures per lesion.
Measured: 1 day
Repeatability: Average Negative Agreement (ANA) of DERM on benign lesions is >50%
Each lesion will be imaged by three users using three sets of the image capture hardware, generating nine data sets (user/hardware combinations) per lesion. Each lesion image data set will consist of 3 repeated measures, resulting in 27 measures per lesion.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start18 Dec 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skin Analytics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654999
- Sponsor's protocol ID
- DERM-011
- Status last verified
- Jul 2025
- First submitted
- 22 Oct 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Subject to constraints in patient consent
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Precision Study To Demonstrate The Repeatability and Reproducability of DERM Outputs
- ClinicalTrials.gov ID
- NCT06654999
- Acronym / sponsor ID
- DERM-011
- Conditions
- Skin Cancer, Melanoma of Skin, Squamous Cell Cancer, Basal Cell Cancer
- Keywords
- Precision, DERM, Repeatability, Reproducability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Skin Analytics LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 23 Oct 2024 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Device: Deep Ensemble for the Recognition of Malignancy (DERM)All patients will have their skin lesion imaged in the same way |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited in specialist dermatology clinics in the UK.
Key inclusion criteria (5 listed)
- Male or Female,
- aged 18 years or above,
- Willing and able to give informed consent for participation in the study,
- Has at least one skin lesion that, following assessment by a primary care provider and a dermatology specialist, will be biopsied due to a high suspicion of skin cancer, and is suitable for assessment by DERM.
- In the Investigator's opinion, able and willing to comply with all study requirements.
Key exclusion criteria (8 listed)
- Patients with more than one skin lesion due for biopsy
- 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.
- To be suitable for inclusion, a skin lesion must NOT have ANY of the following limitations:
- Be located on an anatomical site of different skin structure: palms of hands or soles of feet (acral lesion), mucosal surfaces (lips and eyes) or under nail (ungal lesion),
- Have a diameter greater than the diameter of the dermoscopic lens,
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)DERM variants "+" and "DS" | Device | All patients |
Primary outcome
Reproducibility: Average Positive Agreement (APA) of DERM on malignant lesions is >80%
Time frame: 1 day
Each lesion will be imaged by three users using three sets of the image capture hardware, generating nine data sets (user/hardware combinations) per lesion. Each lesion image data set will consist of 3 repeated measures, resulting in 27 measures per lesion
Repeatability: Average Positive Agreement (APA) of DERM on malignant lesions is >80%
Time frame: 1 day
Each lesion will be imaged by three users using three sets of the image capture hardware, generating nine data sets (user/hardware combinations) per lesion. Each lesion image data set will consist of 3 repeated measures, resulting in 27 measures per lesion.
2 secondary outcomes
Reproducibility: Average Negative Agreement (ANA) of DERM on benign lesions is >50%
Time frame: 1 day
Repeatability: Average Negative Agreement (ANA) of DERM on benign lesions is >50%
Time frame: 1 day
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 9 Jul 2025.
- Individual participant dataSharing planned: Undecided. Subject to constraints in patient consent
Related trials for Skin Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast 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 Skin Cancer and Melanoma of Skin, 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 5 inclusion and 8 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 9 Jul 2025. 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?
Reproducibility: Average Positive Agreement (APA) of DERM on malignant lesions is >80% (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2025.