Malignant Skin Melanoma T0NCT05126173
DERM US and EU Validation Study
An observational study of Malignant Skin Melanoma T0 and Basal Cell Carcinoma, run by Skin Analytics Limited at 16 sites in 2 countries.
Trial summary
This study aims establish the effectiveness of Image Analysing Algorithm (DERM) to identify melanoma, Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) when used to analyse dermoscopic images of skin lesions within the US and European population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Skin Melanoma T0, Basal Cell Carcinoma, Squamous Cell Carcinoma
- What is being tested?
- Deep Ensemble for the Recognition of Malignancy (DERM)
- Type of treatment
- Medical device
- How many people
- 1,111 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 15 Mar 2022to 15 Sep 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
- Adult, Older adult
Study population: Patients attending a dermatology clinic with at least one skin lesion that will be biopsied due to a suspicion of skin cancer will be eligible for the study.
Who may be able to join
- Willing and able to give informed consent for participation in the study,
- Male or Female, aged 18 years or above,
- Have at least one suitable skin lesion that will be biopsied due to a suspicion of skin cancer,
- To be suitable for inclusion, a skin lesion must NOT have ANY of the following limitations:
- 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), a diameter greater than the diameter of the dermoscopic lenses, located on an anatomical site unsuitable for photographing, including on surface of genitals and hair-bearing areas, has been previously biopsied, excised, treated or otherwise traumatised, 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
16 sites in 2 countries.
16 sites in 2 countries
United States10 sites
ALLCUTIS Research, LLC
Beverly, Massachusetts, 01915
Northwestern University
Chicago, Illinois, 60208
Universal Dermatology, PLLC
Fairport, New York, 14450
Alpesh D. Desai, DO, PLLC, a Houston company institution
Houston, Texas, 34761
Allcutis Research
Methuen, Massachusetts, 01844
Vista Health Research, LLC
Miami, Florida, 33176
Dorisca Research Consulting, LLC
Miami, Florida, 34761
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Stanford university
Redwood City, California, 94063
University of Utah
Salt Lake City, Utah, 84112
Italy6 sites
Universitaria Di Bologna
Bologna
Dermatology University of Florence
Florence, 50100
Università degli Studi di Modena e Reggio Emilia
Modena
University of Campania
Naples, 80131
Università del Piemonte Orientale
Novara, 28100
UOSD Dermatology Oncology
Roma
About this study
Official title: A Clinical Validation Study to Demonstrate the Effectiveness of an Artificial Intelligence Algorithm (DERM) to Identify Skin Cancer in Patients Undergoing a Skin Biopsy
This study aims establish the effectiveness of Image Analysing Algorithm (DERM) to identify melanoma, Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) when used to analyse dermoscopic images of skin lesions within the US and European population.
- Being tested
- Deep Ensemble for the Recognition of Malignancy (DERM)
- Medical subject headings
- Carcinoma, Basal Cell, Carcinoma, Squamous 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
An AI-based diagnosis support tool
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of DERM to detect "Malignant conditions"
Sensitivity of DERM to detect Melanoma, SCC and BCC combined
Measured: Through study completion, on average of 1 day
Specificity of DERM to detect Malignant conditions.
Specificity of DERM to detect Melanoma, SCC and BCC combined
Measured: Through study completion, on average of 1 day
Secondary outcomes (7)
Sensitivity of DERM to detect Melanoma
Sensitivity of DERM to detect Melanoma
Measured: Through study completion, on average of 1 day
Specificity of DERM to detect Melanoma
Specificity of DERM to detect Melanoma
Measured: Through study completion, on average of 1 day
Sensitivity of DERM to detect Squamous Cell Carcinoma
Sensitivity of DERM to correctly classify SCC
Measured: Through study completion, on average of 1 day
Specificity of DERM to detect Squamous Cell Carcinoma
Specificity of DERM to correctly classify SCC
Measured: Through study completion, on average of 1 day
Sensitivity of DERM to detect Basal Cell Carcinoma
Sensitivity of DERM to correctly classify BCC
Measured: Through study completion, on average of 1 day
Specificity of DERM to detect Basal Cell Carcinoma
Specificity of DERM to correctly classify BCC
Measured: Through study completion, on average of 1 day
Accuracy of mole/not mole algorithm
Accuracy of mole/not mole algorithm
Measured: Through study completion, on average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start15 Mar 2022
- Primary completion19 Aug 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Skin Melanoma T0Studies 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
- 1,111 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
- NCT05126173
- Sponsor's protocol ID
- DERM-006
- Status last verified
- Jun 2023
- First submitted
- 18 Oct 2021
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Validation Study to Demonstrate the Effectiveness of an Artificial Intelligence Algorithm (DERM) to Identify Skin Cancer in Patients Undergoing a Skin Biopsy
- ClinicalTrials.gov ID
- NCT05126173
- Acronym / sponsor ID
- DERM-006
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,111 participants (actual)
- Lead sponsor
- Skin Analytics LimitedIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 18 Nov 2021 (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 establish the effectiveness of Image Analysing Algorithm (DERM) to identify melanoma, Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) when used to analyse dermoscopic images of skin lesions within the US and European population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients attending a dermatology clinic with at least one skin lesion that will be biopsied due to a suspicion of skin cancer will be eligible for the study.
Key inclusion criteria (6 listed)
- Willing and able to give informed consent for participation in the study,
- Male or Female, aged 18 years or above,
- Have at least one suitable skin lesion that will be biopsied due to a suspicion of skin cancer,
- To be suitable for inclusion, a skin lesion must NOT have ANY of the following limitations:
- 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), a diameter greater than the diameter of the dermoscopic lenses, located on an anatomical site unsuitable for photographing, including on surface of genitals and hair-bearing areas, has been previously biopsied, excised, treated or otherwise traumatised, located in an area of visible scarring or tattooing.
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 | – |
Primary outcome
Sensitivity of DERM to detect "Malignant conditions"
Time frame: Through study completion, on average of 1 day
Sensitivity of DERM to detect Melanoma, SCC and BCC combined
Specificity of DERM to detect Malignant conditions.
Time frame: Through study completion, on average of 1 day
Specificity of DERM to detect Melanoma, SCC and BCC combined
7 secondary outcomes
Sensitivity of DERM to detect Melanoma
Time frame: Through study completion, on average of 1 day
Specificity of DERM to detect Melanoma
Time frame: Through study completion, on average of 1 day
Sensitivity of DERM to detect Squamous Cell Carcinoma
Time frame: Through study completion, on average of 1 day
Specificity of DERM to detect Squamous Cell Carcinoma
Time frame: Through study completion, on average of 1 day
Sensitivity of DERM to detect Basal Cell Carcinoma
Time frame: Through study completion, on average of 1 day
Specificity of DERM to detect Basal Cell Carcinoma
Time frame: Through study completion, on average of 1 day
Accuracy of mole/not mole algorithm
Time frame: Through study completion, on average of 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 28 Jun 2023.
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.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Skin Melanoma T0 and Basal Cell Carcinoma, run by Skin Analytics Limited at 16 sites in 2 countries.
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 6 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 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Italy. 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?
Sensitivity of DERM to detect "Malignant conditions" (time frame: Through study completion, on average of 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 28 Jun 2023.