Clinical trial · Observational
AI-based Medical Device Validation for Early Melanoma Detection
Clinical Validation Study of a CAD System With Artificial Intelligence Algorithms for Early Noninvasive in Vivo Cutaneous Melanoma Detection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Melanoma, Skin | Cutaneous Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-based Computer-Aided Diagnosis (CAD) Software for Skin Lesion Analysis. | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with suspected cutaneous malignancy
- description
- Group/Cohort Description The study group consists of adult patients (over 18 years old) who presented at the Dermatology Departments of Hospital Universitario Cruces and Hospital Universitario Basurto with skin lesions suspected of being malignant. As this is an observational study, participants were not assigned to any new medical interventions, drugs, or treatments as part of the research protocol.
- interventionNames
- Device: AI-based Computer-Aided Diagnosis (CAD) Software for Skin Lesion Analysis.
Primary outcomes (4)
- measure
- Area Under the ROC Curve (AUC) for Melanoma Detection
- timeFrame
- At the time of the single clinical visit (Baseline).
- description
- Measures the device's ability to distinguish between melanoma and non-melanoma cases using predicted probabilities.
- measure
- Accuracy for Melanoma Detection
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available