MelanomaNCT04123678
DERM Health Economics Study
An observational study of Melanoma and Non-melanoma Skin Cancer, run by Skin Analytics Limited at 1 site in United Kingdom.
Trial summary
This study aims to provide an initial assessment of the potential impact DERM could have on the number of onward referrals for a face to face dermatologist review and/or biopsy from a teledermatology-based service, and to improve the understanding of the patient pathways that exist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Non-melanoma Skin Cancer
- What is being tested?
- Deep Ensemble for the Recognition of Malignancy (DERM)
- Type of treatment
- Medical device
- How many people
- 700 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Feb 2020to 6 Aug 2021
- 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
- Adult, Older adult
Study population: Adult patients attending Medical Photography for imaging of at least 1 suspicious skin lesion. Patients may have been referred to the teledermatology service or for imaging for monitoring purposes from the dermatology clinic or for virtual teledermatology review.
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,
- Has at least one suspicious skin lesion which is being photographed as part of Standard of Care (SoC),
- In the Investigators 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 participants 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
1 site in 1 country.
About this study
Official title: Impact of an Artificial Intelligence Platform (DERM) on the Healthcare Resource Utilisation (HRU) Needed to Diagnose Skin Cancer When Used as Part of a United Kingdom-based Teledermatology Service
This study aims to provide an initial assessment of the potential impact DERM could have on the number of onward referrals for a face to face dermatologist review and/or biopsy from a teledermatology-based service, and to improve the understanding of the patient pathways that exist.
Read the detailed description
DERM, an Artificial Intelligence (AI)-based diagnosis support tool, has been shown to be able to accurately identify melanoma, non-melanoma skin cancers (NMSC) and other conditions from historical images of suspicious skin lesions (moles).
This study aims to establish whether the use of DERM in the patient pathway could reduce the number of unnecessary referrals to dermatologist review and/or biopsy.
Suspicious skin lesions that are due to be photographed for a dermatologist to review, will have two additional photographs taken using a commonly available smart phone camera with and without a specific lens attachment. The images will be analysed by DERM, and the results compared to the clinician's diagnosis (all lesions) and histologically-confirmed diagnosis (any lesion that is biopsied).
- Conditions
- Melanoma, Non-melanoma Skin Cancer
- Being tested
- Deep Ensemble for the Recognition of Malignancy (DERM)
- Medical subject headings
- Melanoma
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
AI-based decision support tool
| Study group | Role | What they receive |
|---|---|---|
| All | Patients attending a Medical Photography facility with at least 1 suspicious skin lesion will be approached to participate in the study. Participants will have an additional macro and dermoscopic image of each suspicious skin lesions suitable for photography. Photographs will be taken by a healthcare professional using an iPhone XR smart phone camera with a DL1 dermoscopic lens attachment. The images will be encrypted and electronically transmitted to Skin Analytics' cloud servers for analysis by DERM. The suspected diagnosis determined by DERM will be compared with dermatologist review and histologically confirmed diagnosis, where obtained. Healthcare resource utilization information and patient satisfaction data will also be collected 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.
Referral rate
The rate of unnecessary referrals for a face to face dermatologist review for the same detection rate between standard of care and DERM of lesions reviewed by teledermatology or DERM
Measured: Study completion, on average 5 days
Secondary outcomes (26)
Sensitivity of DERM on biopsied lesions
Sensitivity of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Measured: Study completion, on average 5 days
Specificity of DERM on biopsied lesions
Specificity of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Measured: Study completion, on average 5 days
False positive rate of DERM on biopsied lesions
False positive rate of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Measured: Study completion, on average 5 days
False negative rate of DERM on biopsied lesions
False negative rate of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Measured: Study completion, on average 5 days
Positive predictive value of DERM on biopsied lesions
Positive predictive value of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Measured: Study completion, on average 5 days
Number needed to biopsy by DERM on biopsied lesions
Number needed to biopsy by DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Measured: Study completion, on average 5 days
Sensitivity of teledermatologists on biopsied lesions
Sensitivity of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Measured: Study completion, on average 5 days
Specificity of teledermatologists on biopsied lesions
Specificity of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Measured: Study completion, on average 5 days
False positive rate of teledermatologists on biopsied lesions
False positive rate of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Measured: Study completion, on average 5 days
False negative rate of teledermatologists on biopsied lesions
False negative rate of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Measured: Study completion, on average 5 days
Positive predictive value of teledermatologists on biopsied lesions
Positive predictive value of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Measured: Study completion, on average 5 days
Negative predictive value of teledermatologists on biopsied lesions
Negative predictive value of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Measured: Study completion, on average 5 days
Number needed to biopsy by teledermatologists on biopsied lesions
Number needed to biopsy by teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Measured: Study completion, on average 5 days
Sensitivity of DERM to identify benign conditions
Sensitivity of DERM to identify benign conditions, using clinical diagnosis as gold-standard
Measured: Study completion, on average 5 days
Specificity of DERM to identify benign conditions
Specificity of DERM to identify benign conditions, using clinical diagnosis as gold-standard
Measured: Study completion, on average 5 days
False positive rate of DERM to identify benign conditions
False positive of DERM to identify benign conditions, using clinical diagnosis as gold-standard
Measured: Study completion, on average 5 days
False negative rate of DERM to identify benign conditions
False negative rate of DERM to identify benign conditions, using clinical diagnosis as gold-standard
Measured: Study completion, on average 5 days
Positive predictive value of DERM to identify benign conditions
Positive predictive of DERM to identify benign conditions, using clinical diagnosis as gold-standard
Measured: Study completion, on average 5 days
Negative predictive value of DERM to identify benign conditions
Negative predictive value of DERM to identify benign conditions, using clinical diagnosis as gold-standard
Measured: Study completion, on average 5 days
Number needed to refer by DERM to identify benign conditions
Number needed to refer by DERM to identify benign conditions, using clinical diagnosis as gold-standard
Measured: Study completion, on average 5 days
Concordance of DERM result with clinical diagnosis
Concordance of DERM result with clinical diagnosis
Measured: Study completion, on average 5 days
Percent of patients attending teledermatology by referral route
Percentage of patients referred to teledermatology through 2-week wait referral, general referral, direct to teledermatology, routine follow-up (etc) referral routes
Measured: Study completion, on average 5 days
Time taken from general practitioner (GP) referral to diagnosis
Time taken (days) from GP referral to either histopathology-confirmed or clinical diagnosis
Measured: Study completion, on average 5 days
Estimated cost impact associated with introducing DERM into the patient pathway
The cost of the number of referrals for face to face dermatologist review and/or biopsy that would have been saved / charged if DERM had been used to decide whether to refer the patient onwards
Measured: Study completion, on average 5 days
Proportion of images submitted to DERM that cannot be analysed
Proportion of images submitted to DERM that cannot be analysed
Measured: Study completion, on average 5 days
Patient satisfaction survey
Patient feedback on their experience of the service. Patients will rate whether they agree, or don't agree, with statements that assess their acceptance of having a computer involved in their diagnosis pathway
Measured: Study completion, on average 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start26 Feb 2020
- Primary completion5 Aug 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies 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
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skin Analytics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovate UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123678
- Sponsor's protocol ID
- DERM-005
- Status last verified
- Aug 2021
- First submitted
- 9 Oct 2019
- Last updated
- 13 Aug 2021
- 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
Publications
Marsden H, Kemos P, Venzi M, Noy M, Maheswaran S, Francis N, Hyde C, Mullarkey D, Kalsi D, Thomas L. Accuracy of an artificial intelligence as a medical device as part of a UK-based skin cancer teledermatology service. Front Med (Lausanne). 2024 Mar 22;11:1302363. doi: 10.3389/fmed.2024.1302363. eCollection 2024.
PubMed 38585154
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Artificial Intelligence Platform (DERM) on the Healthcare Resource Utilisation (HRU) Needed to Diagnose Skin Cancer When Used as Part of a United Kingdom-based Teledermatology Service
- ClinicalTrials.gov ID
- NCT04123678
- Acronym / sponsor ID
- DERM-005
- Conditions
- Melanoma, Non-melanoma Skin Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Skin Analytics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Innovate UK
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 5 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 11 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.
This study aims to provide an initial assessment of the potential impact DERM could have on the number of onward referrals for a face to face dermatologist review and/or biopsy from a teledermatology-based service, and to improve the understanding of the patient pathways that exist.
Detailed description
DERM, an Artificial Intelligence (AI)-based diagnosis support tool, has been shown to be able to accurately identify melanoma, non-melanoma skin cancers (NMSC) and other conditions from historical images of suspicious skin lesions (moles).
This study aims to establish whether the use of DERM in the patient pathway could reduce the number of unnecessary referrals to dermatologist review and/or biopsy.
Suspicious skin lesions that are due to be photographed for a dermatologist to review, will have two additional photographs taken using a commonly available smart phone camera with and without a specific lens attachment. The images will be analysed by DERM, and the results compared to the clinician's diagnosis (all lesions) and histologically-confirmed diagnosis (any lesion that is biopsied).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All | – | Device: Deep Ensemble for the Recognition of Malignancy (DERM)Patients attending a Medical Photography facility with at least 1 suspicious skin lesion will be approached to participate in the study. Participants will have an additional macro and dermoscopic image of each suspicious skin lesions suitable for photography. Photographs will be taken by a healthcare professional using an iPhone XR smart phone camera with a DL1 dermoscopic lens attachment. The images will be encrypted and electronically transmitted to Skin Analytics' cloud servers for analysis by DERM. The suspected diagnosis determined by DERM will be compared with dermatologist review and histologically confirmed diagnosis, where obtained. Healthcare resource utilization information and patient satisfaction data will also be collected |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients attending Medical Photography for imaging of at least 1 suspicious skin lesion. Patients may have been referred to the teledermatology service or for imaging for monitoring purposes from the dermatology clinic or for virtual teledermatology review.
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,
- Has at least one suspicious skin lesion which is being photographed as part of Standard of Care (SoC),
- In the Investigators 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 participants 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)AI-based decision support tool | Device | All |
Primary outcome
Referral rate
Time frame: Study completion, on average 5 days
The rate of unnecessary referrals for a face to face dermatologist review for the same detection rate between standard of care and DERM of lesions reviewed by teledermatology or DERM
26 secondary outcomes
Sensitivity of DERM on biopsied lesions
Time frame: Study completion, on average 5 days
Specificity of DERM on biopsied lesions
Time frame: Study completion, on average 5 days
False positive rate of DERM on biopsied lesions
Time frame: Study completion, on average 5 days
False negative rate of DERM on biopsied lesions
Time frame: Study completion, on average 5 days
Positive predictive value of DERM on biopsied lesions
Time frame: Study completion, on average 5 days
Number needed to biopsy by DERM on biopsied lesions
Time frame: Study completion, on average 5 days
Sensitivity of teledermatologists on biopsied lesions
Time frame: Study completion, on average 5 days
Specificity of teledermatologists on biopsied lesions
Time frame: Study completion, on average 5 days
False positive rate of teledermatologists on biopsied lesions
Time frame: Study completion, on average 5 days
False negative rate of teledermatologists on biopsied lesions
Time frame: Study completion, on average 5 days
Positive predictive value of teledermatologists on biopsied lesions
Time frame: Study completion, on average 5 days
Negative predictive value of teledermatologists on biopsied lesions
Time frame: Study completion, on average 5 days
Number needed to biopsy by teledermatologists on biopsied lesions
Time frame: Study completion, on average 5 days
Sensitivity of DERM to identify benign conditions
Time frame: Study completion, on average 5 days
Specificity of DERM to identify benign conditions
Time frame: Study completion, on average 5 days
False positive rate of DERM to identify benign conditions
Time frame: Study completion, on average 5 days
False negative rate of DERM to identify benign conditions
Time frame: Study completion, on average 5 days
Positive predictive value of DERM to identify benign conditions
Time frame: Study completion, on average 5 days
Negative predictive value of DERM to identify benign conditions
Time frame: Study completion, on average 5 days
Number needed to refer by DERM to identify benign conditions
Time frame: Study completion, on average 5 days
Concordance of DERM result with clinical diagnosis
Time frame: Study completion, on average 5 days
Percent of patients attending teledermatology by referral route
Time frame: Study completion, on average 5 days
Time taken from general practitioner (GP) referral to diagnosis
Time frame: Study completion, on average 5 days
Estimated cost impact associated with introducing DERM into the patient pathway
Time frame: Study completion, on average 5 days
Proportion of images submitted to DERM that cannot be analysed
Time frame: Study completion, on average 5 days
Patient satisfaction survey
Time frame: Study completion, on average 5 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 13 Aug 2021.
- Derived from this study: PubMed 38585154Marsden H, Kemos P, Venzi M, Noy M, Maheswaran S, Francis N, Hyde C, Mullarkey D, Kalsi D, Thomas L. Accuracy of an artificial intelligence as a medical device as part of a UK-based skin cancer teledermatology service. Front Med (Lausanne). 2024 Mar 22;11:1302363. doi: 10.3389/fmed.2024.1302363. eCollection 2024.
- Individual participant dataSharing planned: Undecided. Research to improve or test the performance of DERM only allowed in consent
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Non-melanoma Skin Cancer, run by Skin Analytics Limited at 1 site 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 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Referral rate (time frame: Study completion, on average 5 days). 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 NCT04123678, which also lists 1 linked publication.
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 13 Aug 2021.