Clinical Validation Study of a CAD System With Artificial Intelligence Algorithms for Early Non-invasive Detection of in Vivo Cutaneous Melanoma

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The goal of this Cross-sectional analytical observational study of clinical case series is to validate a Computer-aided diagnosis software developed by AI Labs Group for the identification of cutaneous melanoma in images of lesions taken with a dermatoscopic camera. This study will be carried out in patients with skin lesions with suspected malignancy seen at the Dermatology Department of the Cruces University Hospital and Basurto University Hospital. The main questions it aims to answer are: * If the AI algorithm developed by AI Labs group is a valid tool to identify cutaneous melanoma in dermoscopic images with high reliability. * Comparing the device\'s performance with dermatologists, with primary care physicians\' assessment to be considered in later phases. * Assessing the utility and feasibility of the device in adverse environments with technical limitations. In this way, patients with skin lesions with suspected malignancy seen at the Dermatology Department of the Cruces and Basurto University Hospitals will be recruited. Patients in this study will not receive any specific treatment as part of the research protocol. In addition, they will continue their regular prescribed medications and treatments as directed by their primary healthcare providers. This study does not require doing a follow-up of the subjects. Every patient only gets their skin lesions photographed at the time of visit.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
University Hospital of Cruces
RECRUITING
Barakaldo
Contact Information
Primary
Alfonso Medela, MsC
alfonso@legit.health
+34 638127476
Backup
Jordi Barrachina, PhD
jordibarrachina@legit.health
+34 660675578
Time Frame
Start Date: 2020-09-17
Estimated Completion Date: 2024-09
Participants
Target number of participants: 200
Related Therapeutic Areas
Sponsors
Collaborators: Servicio Vasco de Salud Osakidetza, Spain, Hospital de Basurto, Osakidetza, Hospital de Cruces
Leads: AI Labs Group S.L

This content was sourced from clinicaltrials.gov