CompletedNot Applicable

AI-based Medical Device Validation for Early Melanoma Detection

Spain105 participantsStarted 2020-09-17

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area Under the ROC Curve (AUC) for Melanoma Detection

Timeframe: At the time of the single clinical visit (Baseline).

Accuracy for Melanoma Detection

Timeframe: At the time of the single clinical visit (Baseline)

Sensitivity for Melanoma Detection

Timeframe: At the time of the single clinical visit (Baseline).

Specificity for Melanoma Detection

Timeframe: At the time of the single clinical visit (Baseline).

Trial details

NCT IDNCT06221397

SponsorAI Labs Group S.L

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-11-13

Results submitted2026-02-04

View on ClinicalTrials.gov More Melanoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Area Under the ROC Curve (AUC) for Melanoma Detection

Timeframe: At the time of the single clinical visit (Baseline).

Accuracy for Melanoma Detection

Timeframe: At the time of the single clinical visit (Baseline)

Sensitivity for Melanoma Detection

Timeframe: At the time of the single clinical visit (Baseline).

Specificity for Melanoma Detection

Timeframe: At the time of the single clinical visit (Baseline).