NaeviSELF DETECTNCT06999499
Development of an Aid to Melanoma Detection Using Artificial Intelligence Algorithms Based on Images From the VECTRA 3D System.
A study testing Scanner of the whole body using the VECTRA 3D in people with Naevi, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The background to this research is that frequent medical screening of the general population for melanoma is not feasible. The real challenge of this project is to develop an automatic process for detecting any potential melanoma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Naevi
- What is being tested?
- Scanner of the whole body using the VECTRA 3D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2026to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged 18 and over
- Patient with more than 15 nevi (moles) of various phototypes (I to III)
- Patient who has received information about the study and has not expressed any opposition
- Patient who is a beneficiary or entitled person under a social security scheme
Who cannot join
- Patients with phototype V
- Patients with chronic inflammatory skin diseases
- Claustrophobic patients
- Patients who are bedridden or handicapped
- Patients who are excluded from another research protocol at the time of collection of the non-objection.
- Patients covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women),
- Any other reason which, in the investigator's opinion, could interfere with the evaluation of the research objectives.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital de la Conception
Marseille, 13005
Jilliana MONNIER Dr, 0491435817 ext. +33, promotion.interne@ap-hm.fr
About this study
Official title: Development of Artificial Intelligence Algorithms to Help Detect Potential Melanomas, Using Images From the VECTRA 3D Whole Body 360 Imaging System, a 3D Whole-body Skin Scanner.
The background to this research is that frequent medical screening of the general population for melanoma is not feasible. The real challenge of this project is to develop an automatic process for detecting any potential melanoma. To this end, the project aims to design an algorithm to build a novel diagnostic aid that makes use of the similarity and disparity of pigmented lesions in the same patient. To achieve this, we need to obtain and structure a large database of images grouping all pigmented lesions per patient according to their similarities as perceived by dermatologists.
- Conditions
- Naevi
- Being tested
- Scanner of the whole body using the VECTRA 3D
- Medical subject headings
- Nevus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scanner of the whole body using the VECTRA 3DOther
Whole body image acquisition using the VECTRA 3D Whole Body 360 Imaging System to detect potential melanoma
| Study group | Role | What they receive |
|---|---|---|
| Scanner of the whole body sing the VECTRA 3D | Experimental | Whole body image acquisition using the VECTRA 3D Whole Body 360 Imaging System to detect potential melanoma Receives: Other: Scanner of the whole body using the VECTRA 3D |
What is being measured
The primary outcome is the main question the study is designed to answer.
development and validation of algorithms to identify lesions clinically suspected of being melanoma by a dermatologist (potentially malignant and/or ugly duckling).
Comparison of the results given by the analysis of the images by 3 dermatologists or by the software. Estimation of sensitivity and specificity thresholds of at least 93% (accuracy level 5%).
Measured: from enrollement to until 6 month
Secondary outcomes (3)
concordance rate for malignant annotations
concordance between the malignant yes-no annotations of each of the three dermatologists (2 to 2) will be tested.
Measured: From enrollement to 6 month after
concordance rate for ugly duckling
concordance between the ugly duckling yes-no annotations of each of the three dermatologists (2 to 2) will be tested.
Measured: From enrollement to 6 month after
calculation of the proportion of melanomas confirmed by anatomopathology
For each lesion identified as malignant or ugly duckling by the gold standard and removed for histological analysis: calculation of the proportion of melanomas confirmed by pathology.
Measured: From enrollement to 6 month after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NaeviStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999499
- Sponsor's protocol ID
- RCAPHM20_0438
- Other IDs
- 2025-A01109-40
- Acronym
- SELF DETECT
- Status last verified
- Nov 2025
- First submitted
- 20 May 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Artificial Intelligence Algorithms to Help Detect Potential Melanomas, Using Images From the VECTRA 3D Whole Body 360 Imaging System, a 3D Whole-body Skin Scanner.
- ClinicalTrials.gov ID
- NCT06999499
- Acronym / sponsor ID
- SELF DETECT / RCAPHM20_0438
- Conditions
- Naevi
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 31 May 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.
The background to this research is that frequent medical screening of the general population for melanoma is not feasible. The real challenge of this project is to develop an automatic process for detecting any potential melanoma. To this end, the project aims to design an algorithm to build a novel diagnostic aid that makes use of the similarity and disparity of pigmented lesions in the same patient. To achieve this, we need to obtain and structure a large database of images grouping all pigmented lesions per patient according to their similarities as perceived by dermatologists.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scanner of the whole body sing the VECTRA 3D | Experimental | Other: Scanner of the whole body using the VECTRA 3DWhole body image acquisition using the VECTRA 3D Whole Body 360 Imaging System to detect potential melanoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 18 and over
- Patient with more than 15 nevi (moles) of various phototypes (I to III)
- Patient who has received information about the study and has not expressed any opposition
- Patient who is a beneficiary or entitled person under a social security scheme
Key exclusion criteria (7 listed)
- Patients with phototype V
- Patients with chronic inflammatory skin diseases
- Claustrophobic patients
- Patients who are bedridden or handicapped
- Patients who are excluded from another research protocol at the time of collection of the non-objection.
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 |
|---|---|---|
| Scanner of the whole body using the VECTRA 3DWhole body image acquisition using the VECTRA 3D Whole Body 360 Imaging System to detect potential melanoma | Other | Scanner of the whole body sing the VECTRA 3D |
Primary outcome
development and validation of algorithms to identify lesions clinically suspected of being melanoma by a dermatologist (potentially malignant and/or ugly duckling).
Time frame: from enrollement to until 6 month
Comparison of the results given by the analysis of the images by 3 dermatologists or by the software. Estimation of sensitivity and specificity thresholds of at least 93% (accuracy level 5%).
3 secondary outcomes
concordance rate for malignant annotations
Time frame: From enrollement to 6 month after
concordance rate for ugly duckling
Time frame: From enrollement to 6 month after
calculation of the proportion of melanomas confirmed by anatomopathology
Time frame: From enrollement to 6 month after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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Recruiting
CongenItal Naevus Cohort for Longitudinal Evaluation
Naevi, Neurodevelopmental Disorder
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scanner of the whole body using the VECTRA 3D in people with Naevi, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 7 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: opening soon, as of the sponsor's last update on 18 Nov 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jilliana MONNIER Dr (0491435817 ext. +33, promotion.interne@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development and validation of algorithms to identify lesions clinically suspected of being melanoma by a dermatologist (potentially malignant and/or ugly duckling). (time frame: from enrollement to until 6 month). 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 18 Nov 2025; AzTrials last refreshed its copy on 26 Oct 2026.