Melanoma (Skin Cancer)AI-DSIINCT06788665
Investigation of the Performance of the Medical Device Dermalyser in Determining Melanoma Thickness Based on Dermoscopy Images
An observational study of Melanoma (Skin Cancer), run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
In Sweden, approximately 9,000 Swedes are affected by melanoma annually, and each year, 500 individuals die from metastatic melanoma. The prognosis for melanoma primarily depends on the thickness of the tumor at diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin Cancer)
- What is being tested?
- Medical Device Dermalyser
- Type of treatment
- Medical device
- How many people
- 900 participants
- Where
- 1 siteSweden
- Study dates
- 31 Jan 2025to Feb 2026
- 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: The investigational population are patients ≥18 years with suspected cutaneous melanoma with Fitzpatrick skin phototypes I, II, III and IV. We aim to include 300 melanomas with histopathological verification. Importantly, we will include only suspected melanomas, meaning that some lesions will end up being either dysplastic nevi (DN) or other skin tumours. This implies that we need to include up to 600-900 lesions. Considering the non-invasive nature of the investigational product pregnant and breastfeeding women, immune-compromised and elderly subjects will be eligible for inclusion if they fulfil all inclusion criteria.
Who may be able to join
- Patient needs to be ≥18 years of age at inclusion
- The patient has a suspected primary melanoma where surgery is planned
- Willingness and ability to provide informed consent
Who cannot join
- The suspected lesion size is too small or too large to fit the white circle in the screen even after zooming in and out at its maximum. The lesion should not be < 2 mm or > 20 mm in diameter.
- As per judgement by the investigator, to exclude when there are factors that may affect the quality of the photo such as when:
- Lesion with any form of modifications such as tattoos, pen markings, and/or pigments covering or surrounding skin lesions.
- Lesions located on areas such as genitalia, acral skin (foot sole or palm of the hand), mucosal surfaces (mouth, eye, nose, etc.), psoriasis or similar skin conditions.
- Lesions masked by an excessive amount of hair, generally found in armpits, scalp, beards or other hairy parts of the body.
- Lesions that are scarred, non-intact, injured, previously biopsied or undergone surgery. in areas that are not suitable for dermoscopy imaging.
Show all 9Show fewer
- Individuals with skin type V and VI according to the Fitzpatrick scale (darker brown or black coloured skin)
- Patients that do not perform surgery or die before the planned surgery
- Missing or uninterpretable diagnostic data from the Department of Pathology.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Dermatology and Venereology Sahlgrenska University Hospital, Gröna stråket 16
Gothenburg, 413 45
About this study
Official title: Investigation of the Performance of the Medical Device Dermalyser in Determining Melanoma Thickness Based on Dermoscopy Images - A Single-center, Non-randomized, Parallel, and Double-blinded Prospective Clinical Investigation
In Sweden, approximately 9,000 Swedes are affected by melanoma annually, and each year, 500 individuals die from metastatic melanoma. The prognosis for melanoma primarily depends on the thickness of the tumor at diagnosis. Melanomas that only grow in the epidermis and have not yet grown into the dermis are called melanoma in situ or pre-melanoma. These melanomas lack the potential to spread in the body. Melanomas that grow into the dermis, on the other hand, are called invasive or malignant melanomas. Invasive melanomas have the potential to spread in the body.
To improve melanoma diagnostics, a dermatoscope is used. A dermatoscope is a type of magnifying glass equipped with a strong light. Using a dermatoscope makes the structures in the epidermis and dermis clearer. Although most melanomas are relatively easy to detect, it is often difficult to determine whether melanomas are invasive or in situ based on the dermatoscopic image. Despite the fact that all suspected melanomas (regardless of melanoma depth) should be operated on, it is important to form an opinion on whether the melanoma is invasive or in situ. This decision is important because it:
Read more
- Provides guidance on how quickly healthcare must prioritize a patient for surgery.
- Provides guidance on the margin the surgeon chooses for the first operation.
- Affects the information we give the patient even before the first operation.
In recent years, several applications of machine learning have shown great potential in research contexts within dermatology and venereology. However, these tools have been evaluated to a very limited extent in clinical trials, which is naturally a prerequisite before they can be safely implemented in routine healthcare.
- Conditions
- Melanoma (Skin Cancer)
- Being tested
- Medical Device Dermalyser
- Keywords
- melanoma, machine learning, artificial intelligence, diagnostic accuracy, clinical desicion supportive tool, Neoplasms by Histologic Type, Neoplasms, Nevi and Melanomas, Skin Neoplasms, Neoplasms by Site, Skin Diseases
- Medical subject headings
- Melanoma, Neoplasms by Histologic Type, Neoplasms, Nevi and Melanomas, Skin Neoplasms, Neoplasms by Site, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device DermalyserDevice
Dermalyser is an Artificial Intelligence (AI) application (app) that allows medical professionals to take pictures of cutaneous lesions with the help of a smartphone camera. A dermatoscope is connected to the smartphone camera and is used to take the digital image of cutaneous lesions with suspicion of melanoma. Based on image processing algorithms, the app does a detailed analysis of the captured cutaneous lesion. In this clinical investigation, the objective is to test the device performance in a prospective setting in patients with a suspicion of primary cutaneous melanoma, to validate the added AI component. The intended purpose of the device is not to replace the physician's assessment, but rather to assist physicians in their assessment. Consequently, the final device should be regarded as a second opinion to augment clinical decision-making. The ultimate aim is to develop a tool that may augment clinical decision-making.
| Study group | Role | What they receive |
|---|---|---|
| Cutaneous melanoma | Not described Receives: Device: Medical Device Dermalyser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) for discrimination between invansive and in situ melanoma for the "in distribution data set".
Please note that preoperatively there will still be uncertainty if an included lesion will be histopathologically verified as a melanoma. After histopathological analysis all lesions will be separated into an "in distrubution data set", i.e. lesions that were confirmed as melanomas and an "out-of distribution set", i.e., lesions that proved to have an alternative diagnosis.
Please note that the primary outcome measure will be limited the "in distrubution data set", i.e., lesions that turned out to be a melanoma. Image analysis with the help of AI tool Dermalyser in a prospective setting.
Measured: From enrollment to the end of the inclusion when the images of the lesion have been obtained. This will most often be achieved on the same day as that the patient is included in the study.
Secondary outcomes (1)
Sensitivity and Specificity
Please note that preoperatively there will still be uncertainty if an included lesion will be histopathologically verified as a melanoma. After histopathological analysis all lesions will be separated into an "in distrubution data set", i.e. lesions that were confirmed as melanomas and an "out-of distribution set", i.e., lesions that proved to have an alternative diagnosis.
Please note that the sensitivity and specificity measure will be limited the "in distrubution data set", i.e., lesions that turned out to be a melanoma. Image analysis with the help of AI tool Dermalyser in a prospective setting.
Measured: From enrollment to the end of the inclusion when the images of the lesion have been obtained. This will most often be achieved on the same day as that the patient is included in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start31 Jan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788665
- Sponsor's protocol ID
- CIV-24-06-047957
- Acronym
- AI-DSII
- Status last verified
- Oct 2024
- First submitted
- 16 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Performance of the Medical Device Dermalyser in Determining Melanoma Thickness Based on Dermoscopy Images - A Single-center, Non-randomized, Parallel, and Double-blinded Prospective Clinical Investigation
- ClinicalTrials.gov ID
- NCT06788665
- Acronym / sponsor ID
- AI-DSII / CIV-24-06-047957
- Conditions
- Melanoma (Skin Cancer)
- Keywords
- melanoma, machine learning, artificial intelligence, diagnostic accuracy, clinical desicion supportive tool, Neoplasms by Histologic Type, Neoplasms, Nevi and Melanomas
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 31 Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 23 Jan 2025 (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.
In Sweden, approximately 9,000 Swedes are affected by melanoma annually, and each year, 500 individuals die from metastatic melanoma. The prognosis for melanoma primarily depends on the thickness of the tumor at diagnosis. Melanomas that only grow in the epidermis and have not yet grown into the dermis are called melanoma in situ or pre-melanoma. These melanomas lack the potential to spread in the body. Melanomas that grow into the dermis, on the other hand, are called invasive or malignant melanomas. Invasive melanomas have the potential to spread in the body.
To improve melanoma diagnostics, a dermatoscope is used. A dermatoscope is a type of magnifying glass equipped with a strong light. Using a dermatoscope makes the structures in the epidermis and dermis clearer. Although most melanomas are relatively easy to detect, it is often difficult to determine whether melanomas are invasive or in situ based on the dermatoscopic image. Despite the fact that all suspected melanomas (regardless of melanoma depth) should be operated on, it is important to form an opinion on whether the melanoma is invasive or in situ. This decision is important because it:
- Provides guidance on how quickly healthcare must prioritize a patient for surgery.
- Provides guidance on the margin the surgeon chooses for the first operation.
- Affects the information we give the patient even before the first operation.
In recent years, several applications of machine learning have shown great potential in research contexts within dermatology and venereology. However, these tools have been evaluated to a very limited extent in clinical trials, which is naturally a prerequisite before they can be safely implemented in routine healthcare.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cutaneous melanoma | – | Device: Medical Device Dermalyser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigational population are patients ≥18 years with suspected cutaneous melanoma with Fitzpatrick skin phototypes I, II, III and IV. We aim to include 300 melanomas with histopathological verification. Importantly, we will include only suspected melanomas, meaning that some lesions will end up being either dysplastic nevi (DN) or other skin tumours. This implies that we need to include up to 600-900 lesions. Considering the non-invasive nature of the investigational product pregnant and breastfeeding women, immune-compromised and elderly subjects will be eligible for inclusion if they fulfil all inclusion criteria.
Key inclusion criteria (3 listed)
- Patient needs to be ≥18 years of age at inclusion
- The patient has a suspected primary melanoma where surgery is planned
- Willingness and ability to provide informed consent
Key exclusion criteria (9 listed)
- The suspected lesion size is too small or too large to fit the white circle in the screen even after zooming in and out at its maximum. The lesion should not be < 2 mm or > 20 mm in diameter.
- As per judgement by the investigator, to exclude when there are factors that may affect the quality of the photo such as when:
- Individuals with skin type V and VI according to the Fitzpatrick scale (darker brown or black coloured skin)
- Patients that do not perform surgery or die before the planned surgery
- Missing or uninterpretable diagnostic data from the Department of Pathology.
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 |
|---|---|---|
| Medical Device DermalyserDermalyser is an Artificial Intelligence (AI) application (app) that allows medical professionals to take pictures of cutaneous lesions with the help of a smartphone camera. A dermatoscope is connected to the smartphone camera and is used to take the digital image of cutaneous lesions with suspicion of melanoma. Based on image processing algorithms, the app does a detailed analysis of the captured cutaneous lesion. In this clinical investigation, the objective is to test the device performance in a prospective setting in patients with a suspicion of primary cutaneous melanoma, to validate the added AI component. The intended purpose of the device is not to replace the physician's assessment, but rather to assist physicians in their assessment. Consequently, the final device should be regarded as a second opinion to augment clinical decision-making. The ultimate aim is to develop a tool that may augment clinical decision-making. | Device | Cutaneous melanoma |
Primary outcome
Area under the curve (AUC) for discrimination between invansive and in situ melanoma for the "in distribution data set".
Time frame: From enrollment to the end of the inclusion when the images of the lesion have been obtained. This will most often be achieved on the same day as that the patient is included in the study.
Please note that preoperatively there will still be uncertainty if an included lesion will be histopathologically verified as a melanoma. After histopathological analysis all lesions will be separated into an "in distrubution data set", i.e. lesions that were confirmed as melanomas and an "out-of distribution set", i.e., lesions that proved to have an alternative diagnosis. Please note that the primary outcome measure will be limited the "in distrubution data set", i.e., lesions that turned out to be a melanoma. Image analysis with the help of AI tool Dermalyser in a prospective setting.
1 secondary outcome
Sensitivity and Specificity
Time frame: From enrollment to the end of the inclusion when the images of the lesion have been obtained. This will most often be achieved on the same day as that the patient is included in the study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 (Skin Cancer), run by Vastra Gotaland Region at 1 site 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: status not confirmed, as of the sponsor's last update on 23 Jan 2025. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sam Polesie, MD, PhD (+4670-2241915, sam.polesie@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) for discrimination between invansive and in situ melanoma for the "in distribution data set". (time frame: From enrollment to the end of the inclusion when the images of the lesion have been obtained. This will most often be achieved on the same day as that the patient is included in the study.). 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 23 Jan 2025.