Using an Artificial Intelligence Medical Device to Help Primary Care Practitioners Identify and M… (NCT07429123) | Clinical Trial Compass
CompletedNot Applicable
Using an Artificial Intelligence Medical Device to Help Primary Care Practitioners Identify and Manage Skin Conditions (Tumor, Inflammatory, and Infectious Diseases) in Adult Patients at Pozuelo and Majadahonda Health Centers
Spain131 participantsStarted 2022-06-24
Plain-language summary
The goal of this observational study is to learn if an artificial intelligence (AI) tool helps primary care practitioners better identify skin conditions. The study focuses on adults with suspected skin pathologies, including tumor, inflammatory, and infectious diseases.
The main questions it aims to answer are:
* Does using the AI tool help doctors make more accurate diagnoses for multiple skin conditions?
* Does the tool help doctors better decide which patients need a referral to a dermatologist and which can be managed in primary care?
* Are doctors satisfied with how well the tool works and how easy it is to use in their daily work?
* Can the tool help doctors more accurately differentiate between benign lesions and skin cancer?
Participants will:
* Visit their primary care doctor for a regular skin checkup.
* Have photos taken of their skin condition using a smartphone or a dermatoscope.
* Provide informed consent for their photos and basic health information (such as age and sex) to be analyzed by the AI tool.
* Receive standard care from their doctor, with the tool providing a second opinion to assist in the clinical decision-making process.
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:
* Tumor pathology:
* Benign:
* Histiocytoma
* Seborrheic keratosis
* Angiomas
* Precancerous:
* Actinic keratosis
* Suspected malignancy:
* Basal cell carcinoma
* Squamous cell carcinoma
* Pigmented lesions:
* Melanocytic nevus
* Malignant melanoma
* Inflammatory pathology:
* Psoriasis
* Atopic dermatitis
* Urticaria
* Hidradenitis suppurativa
* Lichen planus
* Infectious pathology:
* Viral warts
* Molluscs
* Herpes simplex
* Patients aged 18 years or older.
* Patients who have signed the informed consent for the study.
Exclusion Criteria:
* Patients under 18 years of age.
* Pregnant patients.
* Patients who, in the opinion of the researcher, will not comply with the study procedures.
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.