N/A
N=105
AI-based Medical Device Validation for Early Melanoma Detection
Melanoma · Melanoma, Skin
Bottom Line
View on ClinicalTrials.gov: NCT06221397 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Area Under the ROC Curve (AUC) for Melanoma Detection — 0.8482 Probability area (value from 0 to 1)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- AI-based Computer-Aided Diagnosis (CAD) Software for Skin Lesion Analysis. (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AI Labs Group S.L
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the ROC Curve (AUC) for Melanoma Detection |
0.8482 | — |
| PRIMARY Accuracy for Melanoma Detection |
0.81 | — |
| PRIMARY Sensitivity for Melanoma Detection |
0.93 | — |
| PRIMARY Specificity for Melanoma Detection |
0.80 | — |
| SECONDARY Top-1 Accuracy for Multiple ICD Categories |
0.55 | — |
| SECONDARY Top-3 Accuracy for Multiple ICD Categories |
0.7569 | — |
| SECONDARY Top-5 Accuracy for Multiple ICD Categories |
0.8422 | — |
| SECONDARY Area Under the ROC Curve (AUC) for Malignancy Detection |
0.90 | — |
| SECONDARY Sensitivity for Multiple Malignant Conditions Detection |
0.81 | — |
| SECONDARY Specificity for Multiple Malignant Conditions Detection |
0.86 | — |
| SECONDARY Predictive Values (PPV and NPV) for Malignancy |
0.9247; 0.6789 | — |
Summary
The goal of this observational study is to learn if a computer-aided diagnosis (CAD) system can help identify skin cancer (cutaneous melanoma). The research focuses on adults who have skin spots that a doctor thinks might be cancerous. The main questions the study aims to answer are:
Can the artificial intelligence (AI) tool accurately identify melanoma in skin images?
How does the tool's accuracy compare to the clinical judgment of expert skin doctors (dermatologists)?
Researchers will compare the results from the AI tool to the final diagnosis made by doctors or through a skin biopsy. A biopsy is a medical test where a small piece of skin is removed and checked in a lab.
Participants will:
Have their skin spots photographed using a special camera attached to a smartphone.
Allow researchers to use their clinical data and biopsy results for the study.
The study does not change the medical care participants receive. Doctors will continue to treat participants as they normally would. By testing this tool, researchers hope to find a way to detect skin cancer earlier and more accurately
Eligibility Criteria
Inclusion Criteria
- Patients with skin lesions with suspected malignancy
- Age over 18 years old
- Patients who consent to participate in the study by signing the Informed Consent form
Exclusion Criteria
- Patients under 18 years of age
Data sourced from ClinicalTrials.gov (NCT06221397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.