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Not yet recruitingNCT06999499SELF DETECTUpdated Oct 28, 2026

Development of an Aid to Melanoma Detection Using Artificial Intelligence Algorithms Based on Images From the VECTRA 3D System.

An interventional study of Scanner of the whole body using the VECTRA 3D in Naevi, sponsored by Assistance Publique Hopitaux De Marseille. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic

Updated Oct 28, 2026Start date movedStudy contact changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Naevi

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03

In context

Nevus

47 studies on the registry are indexed under Nevus; 9 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 100 across 19 interventional studies indexed under Nevus.

Browse Nevus studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    Scanner of the whole body sing the VECTRA 3D

    Whole body image acquisition using the VECTRA 3D Whole Body 360 Imaging System to detect potential melanoma

    Other: Scanner of the whole body using the VECTRA 3D

Interventions

  • OtherScanner of the whole body using the VECTRA 3D

    Whole body image acquisition using the VECTRA 3D Whole Body 360 Imaging System to detect potential melanoma

06

What researchers measure

Primary outcomes

  1. 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%).

    Time frame: from enrollement to until 6 month

Secondary outcomes

  1. concordance rate for malignant annotations

    concordance between the malignant yes-no annotations of each of the three dermatologists (2 to 2) will be tested.

    Time frame: From enrollement to 6 month after

  2. 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.

    Time frame: From enrollement to 6 month after

  3. 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.

    Time frame: From enrollement to 6 month after

07

Study locations

1 site
08

Updates

1 registry update since Sep 25, 2026
Start date
Mar 1, 2026→Jan 1, 2027
Oct 28, 2026
Contact
Study contact's phone or email changed: p•••@ap-hm.fr→J•••@ap-hm.fr. See the current contact
Oct 28, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Hôpital de la Conception · Marseille, FranceContact p•••@ap-hm.fr→J•••@ap-hm.fr
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    Start date Mar 1, 2026→Jan 1, 2027
    Contact Study contact's phone or email changed: p•••@ap-hm.fr→J•••@ap-hm.fr. See the current contact
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Hôpital de la Conception · Marseille, FranceContact p•••@ap-hm.fr→J•••@ap-hm.fr
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06999499
Responsible party
Sponsor
First posted
May 31, 2025
Start date
Jan 1, 2027 (estimated)
Primary completion
Mar 1, 2028 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Oct 28, 2026

Study contacts

Jilliana MONNIER Dr
Contact
Jilliana.MONNIER@ap-hm.fr
0491435817 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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