Malignant MelanomaAI-DSMMNCT05172232
Diagnostic Precision of the AI Tool Dermalyzer to Identify Malignant Melanomas in Subjects Seeking Primary Care for Melanoma-suspected Cutaneous Lesions
An observational study of Malignant Melanoma, run by Linkoeping University at 3 sites in Sweden.
Trial summary
Dermalyzer is a device intended to be used as a decision support system for assessing cutaneous lesions suspected of being melanomas. The input from the device is not intended to be used as the sole source of information for diagnosis. Intended to be used by medical professionals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Dermalyzer
- How many people
- 231 participants
- Where
- 3 sitesSweden
- Study dates
- 2 May 2022to 23 Jan 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Primary care patients
Who may be able to join
- Patients ≥18 years
- Patients attending a primary care facility with at least 1 suspicious skin lesion where malignant melanoma cannot be ruled out.
- Willingness and ability to provide informed consent.
Who cannot join
- Cutaneous lesions that are considered as benign by the investigator and thus not subject for further clinical investigation
- Cutaneous lesions in areas that are not suitable for dermoscopy imaging
- Cutaneous lesions in areas with any form of scarring of tissue due to injury
- Damaged or injured non intact skin where the cutaneous lesion is located
- Individuals with skin type V and VI according to the Fitzpatrick scale (darker brown or black coloured skin)
- Cutaneous lesions in areas covered by tattoos
Show all 9Show fewer
- Cutaneous lesions in abundantly hairy skin areas (provided the the area cannot be shaved freely from the hair to allow clear view for the dermatoscope)
- Images where the entire lesion is not inside the photo
- Images that are out of focus
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Region Östergötland Primary Care
Linköping, Docent, 58185
Region Stockholm Primary Care
Stockholm
Region Kalmar and Kronoberg
Vaxjo
About this study
Official title: A Prospective Clinical Investigation to Assess the Diagnostic Precision of the AI Tool Dermalyzer to Identify Malignant Melanomas in Subjects Seeking Primary Care for Melanoma-suspected Cutaneous Lesions
Dermalyzer is a device intended to be used as a decision support system for assessing cutaneous lesions suspected of being melanomas. The input from the device is not intended to be used as the sole source of information for diagnosis. Intended to be used by medical professionals. The service does not provide any other diagnosis. The study is a pre-marketing, prospective, confirmatory, first in clinical setting, pivotal multi-centre, non-interventional clinical investigation to evaluate the clinical safety, performance and benefit of Dermalyzer in patients with cutaneous lesions where malignant melanoma (MM) cannot be ruled out.
Primary objective: The primary objective of the investigation is to determine the diagnostic precision of the device; to answer at which level the AI tool Dermalyzer can identify malignant melanomas among cutaneous lesions that are assessed in clinical use due to any degree of malignancy suspicion.
Read more
Secondary objectives: A) To evaluate usability and applicability in clinical praxis of Dermalyzer by users (medical professionals), B)To gain an increased knowledge and understanding of how digital tools enhanced co-artificial intelligence can assist physicians with the right support for an earlier diagnosis of malignant melanoma.
Exploratory objective: To explore health economic aspects of improved diagnosis support
Methods: The subjects will be included from around 30 primary care centers in Sweden. If the subject's lesion(s) is suspected of melanoma or melanoma cannot be ruled out, the subject is asked to participate in the investigation. The investigator examines the subject's lesion(s) and makes the clinical assessment of the subject lesion(s) based on established clinical decision algorithms The investigator takes dermoscopy images according to standard of care and archives the image(s) according to clinical routine. The investigator decides on action, based on his or her MM suspicion (excision at the primary care center or referral for excision or referral to a dermatologist for further assessment). The investigator takes images of the lesion(s) again, this time with a mobile phone, containing the AI software, connected to a dermatoscope, and follows the on-screen instructions. The image is processed by the AI and the results are visible on the screen within seconds. The investigator records how he considers that the degree of suspicion of MM (higher vs lower) would have been affected by the AI SW result if it had been the governing body for the treatment. At study follow-up, the final tumor diagnosis from the histopathology results (melanoma/non melanoma) or by dermatologist assessment (if stated as undoubtedly benign), the degree of agreement between the true final diagmosis and the outcome of the AI decision support is determined, and the diagnostic accuracy in distinguishing melanoma from non-melanoma, in terms of sensitivity and specificity as well the positive and predictive value. The corresponding comparison is performed from the examining investigators estimated clinical degree of suspicion. The clinical investigation will collect information from the users, how participating users (investigators at the site) experience the usability of the AI decision support and attaching applications, from short surveys including the validated System Usability Scale.
Read the detailed description
Background: Malignant melanoma is a worldwide health issue of concern, of increasing incidence. Early melanoma detection is crucial for survival and prognosis. Dermalyzer is a device intended to be used as a decision support system for assessing cutaneous lesions suspected of being melanomas, based on artificial intelligence (AI), often referred to as "machine learning". The input from the device is not intended to be used as the sole source of information for diagnosis. Intended to be used by medical professionals. The service does not provide any other diagnosis.
Study aims/objectives:
Primary objective: The primary objective of the investigation is to determine the diagnostic precision of the device; to answer at which level the AI tool Dermalyzer can identify malignant melanomas among cutaneous lesions that are assessed in clinical use due to any degree of malignancy suspicion.
Secondary objectives: A) To evaluate usability and applicability in clinical praxis of Dermalyzer by users (medical professionals), and B) To gain an increased knowledge and understanding of how digital tools enhanced co-artificial intelligence can assist physicians with the right support for an earlier diagnosis of malignant melanoma.
Exploratory objective: To explore health economic aspects of improved diagnosis support Exploratory endpoints
Materials \& methods:
The subjects will be included from around 30 primary care centers in Sweden. If the subject's lesion(s) is suspected of melanoma or melanoma cannot be ruled out, the subject is asked to participate in the investigation. The investigator examines the subject's lesion(s) and makes the clinical assessment of the subject lesion(s) based on established clinical decision algorithms (such as "Chaos \& clues", "3- or 7-point checklist", or the ABCDE concept) of whether there is a suspicion of MM, according to the usual clinical routine (also includes very low suspicion of MM but cannot be completely dismissed). The investigator takes dermoscopy images according to standard of care and archives the image(s) according to clinical routine. The investigator decides on action, based on his or her MM suspicion (excision at the primary care center or referral for excision or referral to a dermatologist for further assessment). If the subject has agreed to participate in the investigation, the investigator indicates in the CRF the clinical suspicion level of MM, and decided action. The investigator takes images of the lesion(s) again, this time with a mobile phone, containing the IMD AI SW, connected to a dermatoscope, and follows the on-screen instructions. The image is processed by the AI SW and the results are visible on the screen within seconds. A unique auto generated code number is also presented. The code number is registered on the enrollment log and in the CRF. The investigator records how he considers that the degree of suspicion of MM (higher vs lower) would have been affected by the AI SW result if it had been the governing body for the treatment.
When the subject has been fully examined and receives the final tumor diagnosis from the histopathology/PAD results or dermatologist assessment (melanoma/non melanoma), the degree of agreement between the PAD and the outcome of the AI SW decision support is calculated with the Kappa-analysis and the diagnostic accuracy to be able to distinguish melanoma from non-melanoma in the form of sensitivity and specificity as well the positive and predictive value. The corresponding comparison is performed from the examining investigators estimated clinical degree of suspicion, as well as the diagnostic accuracy when both the PAD and the AI decision support are wigheted together (ei in cases where the investigator and the decisions support are in agreement in their assessment). The clinical investigation will collect information from the users, how participating users (investigators at the site) experience the usability of the AI SW decision support and attaching applications, from short surveys including the validated System Usability Scale.
- Conditions
- Malignant Melanoma
- Being tested
- Dermalyzer
- Keywords
- artificial intelligence, diagnostic accuracy, clinical desicion supportive tool
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermalyzerDiagnostic test
To evaluate the diagnostic accuracy of the Dermalyzer device to detect melanoma among cutaneos skin lesions by dermoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Primary care patients with melanoma suspicious skin lesion(s) | Patients seeking primary care, having one or more skin lesion that the primary care physician cannot by certainty can rule out as being a possible melanoma. Receives: Diagnostic Test: Dermalyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy to Detect Melanoma
The number of correctly classified skin lesions by the Dermalyzer (melanoma vs not melanoma), as compared with the result of the standard diagnostic procedure (dermatologist assessment and histoptahologic analysis).
Measured: 12 months
Secondary outcomes (1)
Instrument Usability of the Device
User experience and perception of the Dermalyzer, in the form of System Usability Scale, to evaluate the usability and applicability in clinical praxis. The validated scale conists of 10 Likert scale based questions (scored 1-5 points), reflecting different aspects of usability, such as easiness to use, complexity, inconsistensy, understandability, etc. It summurizes in a score ranging from 0 - 100 points, where a high score reflects good usability properties.
Measured: Secondary measurement variable data was collected after baseline primary data inclusion was ended in Feb 2022, and completeted within 3 months from that.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start2 May 2022
- Primary completion23 Jan 2023
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet, Region Östergötland, Region Stockholm, Landstinget i Kalmar Län, Kronoberg County Council
- Responsible party
- Principal investigator, Magnus Falk, Linkoeping University
- Investigators
- Magnus Falk, Ass.Prof., Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172232
- Sponsor's protocol ID
- CIV-21-12-038346
- Acronym
- AI-DSMM
- Status last verified
- Jan 2025
- First submitted
- 23 Dec 2021
- Last updated
- 5 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Investigation to Assess the Diagnostic Precision of the AI Tool Dermalyzer to Identify Malignant Melanomas in Subjects Seeking Primary Care for Melanoma-suspected Cutaneous Lesions
- ClinicalTrials.gov ID
- NCT05172232
- Acronym / sponsor ID
- AI-DSMM / CIV-21-12-038346
- Conditions
- Malignant Melanoma
- Keywords
- artificial intelligence, diagnostic accuracy, clinical desicion supportive tool
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Karolinska Institutet, Region Östergötland, Region Stockholm, Landstinget i Kalmar Län, Kronoberg County Council
- Study start
- 2 May 2022 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Posted 5 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dermalyzer is a device intended to be used as a decision support system for assessing cutaneous lesions suspected of being melanomas. The input from the device is not intended to be used as the sole source of information for diagnosis. Intended to be used by medical professionals. The service does not provide any other diagnosis. The study is a pre-marketing, prospective, confirmatory, first in clinical setting, pivotal multi-centre, non-interventional clinical investigation to evaluate the clinical safety, performance and benefit of Dermalyzer in patients with cutaneous lesions where malignant melanoma (MM) cannot be ruled out.
Primary objective: The primary objective of the investigation is to determine the diagnostic precision of the device; to answer at which level the AI tool Dermalyzer can identify malignant melanomas among cutaneous lesions that are assessed in clinical use due to any degree of malignancy suspicion.
Secondary objectives: A) To evaluate usability and applicability in clinical praxis of Dermalyzer by users (medical professionals), B)To gain an increased knowledge and understanding of how digital tools enhanced co-artificial intelligence can assist physicians with the right support for an earlier diagnosis of malignant melanoma.
Exploratory objective: To explore health economic aspects of improved diagnosis support
Methods: The subjects will be included from around 30 primary care centers in Sweden. If the subject's lesion(s) is suspected of melanoma or melanoma cannot be ruled out, the subject is asked to participate in the investigation. The investigator examines the subject's lesion(s) and makes the clinical assessment of the subject lesion(s) based on established clinical decision algorithms The investigator takes dermoscopy images according to standard of care and archives the image(s) according to clinical routine. The investigator decides on action, based on his or her MM suspicion (excision at the primary care center or referral for excision or referral to a dermatologist for further assessment). The investigator takes images of the lesion(s) again, this time with a mobile phone, containing the AI software, connected to a dermatoscope, and follows the on-screen instructions. The image is processed by the AI and the results are visible on the screen within seconds. The investigator records how he considers that the degree of suspicion of MM (higher vs lower) would have been affected by the AI SW result if it had been the governing body for the treatment. At study follow-up, the final tumor diagnosis from the histopathology results (melanoma/non melanoma) or by dermatologist assessment (if stated as undoubtedly benign), the degree of agreement between the true final diagmosis and the outcome of the AI decision support is determined, and the diagnostic accuracy in distinguishing melanoma from non-melanoma, in terms of sensitivity and specificity as well the positive and predictive value. The corresponding comparison is performed from the examining investigators estimated clinical degree of suspicion. The clinical investigation will collect information from the users, how participating users (investigators at the site) experience the usability of the AI decision support and attaching applications, from short surveys including the validated System Usability Scale.
Detailed description
Background: Malignant melanoma is a worldwide health issue of concern, of increasing incidence. Early melanoma detection is crucial for survival and prognosis. Dermalyzer is a device intended to be used as a decision support system for assessing cutaneous lesions suspected of being melanomas, based on artificial intelligence (AI), often referred to as "machine learning". The input from the device is not intended to be used as the sole source of information for diagnosis. Intended to be used by medical professionals. The service does not provide any other diagnosis.
Study aims/objectives:
Primary objective: The primary objective of the investigation is to determine the diagnostic precision of the device; to answer at which level the AI tool Dermalyzer can identify malignant melanomas among cutaneous lesions that are assessed in clinical use due to any degree of malignancy suspicion.
Secondary objectives: A) To evaluate usability and applicability in clinical praxis of Dermalyzer by users (medical professionals), and B) To gain an increased knowledge and understanding of how digital tools enhanced co-artificial intelligence can assist physicians with the right support for an earlier diagnosis of malignant melanoma.
Exploratory objective: To explore health economic aspects of improved diagnosis support Exploratory endpoints
Materials \& methods:
The subjects will be included from around 30 primary care centers in Sweden. If the subject's lesion(s) is suspected of melanoma or melanoma cannot be ruled out, the subject is asked to participate in the investigation. The investigator examines the subject's lesion(s) and makes the clinical assessment of the subject lesion(s) based on established clinical decision algorithms (such as "Chaos \& clues", "3- or 7-point checklist", or the ABCDE concept) of whether there is a suspicion of MM, according to the usual clinical routine (also includes very low suspicion of MM but cannot be completely dismissed). The investigator takes dermoscopy images according to standard of care and archives the image(s) according to clinical routine. The investigator decides on action, based on his or her MM suspicion (excision at the primary care center or referral for excision or referral to a dermatologist for further assessment). If the subject has agreed to participate in the investigation, the investigator indicates in the CRF the clinical suspicion level of MM, and decided action. The investigator takes images of the lesion(s) again, this time with a mobile phone, containing the IMD AI SW, connected to a dermatoscope, and follows the on-screen instructions. The image is processed by the AI SW and the results are visible on the screen within seconds. A unique auto generated code number is also presented. The code number is registered on the enrollment log and in the CRF. The investigator records how he considers that the degree of suspicion of MM (higher vs lower) would have been affected by the AI SW result if it had been the governing body for the treatment.
When the subject has been fully examined and receives the final tumor diagnosis from the histopathology/PAD results or dermatologist assessment (melanoma/non melanoma), the degree of agreement between the PAD and the outcome of the AI SW decision support is calculated with the Kappa-analysis and the diagnostic accuracy to be able to distinguish melanoma from non-melanoma in the form of sensitivity and specificity as well the positive and predictive value. The corresponding comparison is performed from the examining investigators estimated clinical degree of suspicion, as well as the diagnostic accuracy when both the PAD and the AI decision support are wigheted together (ei in cases where the investigator and the decisions support are in agreement in their assessment). The clinical investigation will collect information from the users, how participating users (investigators at the site) experience the usability of the AI SW decision support and attaching applications, from short surveys including the validated System Usability Scale.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary care patients with melanoma suspicious skin lesion(s) | – | Diagnostic Test: DermalyzerPatients seeking primary care, having one or more skin lesion that the primary care physician cannot by certainty can rule out as being a possible melanoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care patients
Key inclusion criteria (3 listed)
- Patients ≥18 years
- Patients attending a primary care facility with at least 1 suspicious skin lesion where malignant melanoma cannot be ruled out.
- Willingness and ability to provide informed consent.
Key exclusion criteria (9 listed)
- Cutaneous lesions that are considered as benign by the investigator and thus not subject for further clinical investigation
- Cutaneous lesions in areas that are not suitable for dermoscopy imaging
- Cutaneous lesions in areas with any form of scarring of tissue due to injury
- Damaged or injured non intact skin where the cutaneous lesion is located
- Individuals with skin type V and VI according to the Fitzpatrick scale (darker brown or black coloured skin)
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 |
|---|---|---|
| DermalyzerTo evaluate the diagnostic accuracy of the Dermalyzer device to detect melanoma among cutaneos skin lesions by dermoscopy. | Diagnostic test | Primary care patients with melanoma suspicious skin lesion(s) |
Primary outcome
Diagnostic Accuracy to Detect Melanoma
Time frame: 12 months
The number of correctly classified skin lesions by the Dermalyzer (melanoma vs not melanoma), as compared with the result of the standard diagnostic procedure (dermatologist assessment and histoptahologic analysis).
1 secondary outcome
Instrument Usability of the Device
Time frame: Secondary measurement variable data was collected after baseline primary data inclusion was ended in Feb 2022, and completeted within 3 months from that.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Magnus Falk, Ass.Prof. principal investigator
Linkoeping University
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 Malignant Melanoma, run by Linkoeping University at 3 sites in Sweden.
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 3 inclusion and 9 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 5 Feb 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 Sweden. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Diagnostic Accuracy to Detect Melanoma (time frame: 12 months). 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 5 Feb 2025.