Study identification

PURI

https://redirect.ema.europa.eu/resource/108436

EU PAS number

EUPAS108254

Study ID

108436

Official title and acronym

Clinical validation study of a CAD system with artificial intelligence algorithms for early non-invasive detection of in vivo cutaneous melanoma. (LEGIT_MC_EVCDAO_2019)

DARWIN EU® study

No

Study countries

Spain

Study description

The SARS-CoV-2 pandemic poses challenges to global healthcare systems, impacting the care of COVID-19 patients and causing disruptions in various medical disciplines, including dermatology. Urgent measures, initiated almost two years ago, aimed to prioritize COVID-19 cases, resulting in a backlog of non-urgent consultations. Dermatology practices were considered potential vectors of COVID-19 transmission, leading to the suspension of non-urgent consultations. The ongoing threat from evolving virus variants has hindered the restoration of normal healthcare flows. In response, an alternative system is imperative for efficient and timely diagnosis and remote patient monitoring. The imbalance in dermatologist-to-patient ratios, especially in Spain and other European countries, accentuates the need for such a system. Delayed diagnosis of skin conditions, including potentially life-threatening melanoma, and exacerbation of chronic diseases during the pandemic underscore the urgency. Currently, no reliable tools exist for remote pathology diagnosis, emphasizing the importance of implementing an innovative solution. Human limitations in quantifying parameters and inherent biases in patient-reported measurement scales further impede accurate assessments. The inadequacy of existing methods, coupled with the reluctance of patients to seek in-person consultations during the pandemic, highlights the necessity for advanced diagnostic tools. The study advocates for the clinical validation of an artificial intelligence tool, Legit.Health, designed to grade disease activity in dermatological patients. Artificial intelligence, particularly Computer Aided Diagnosis (CAD) systems, offers a promising avenue. These systems, leveraging artificial intelligence and image processing, enhance the interpretation of medical images, demonstrating competence comparable to medical experts.

Study status

Finalised
Research institution and networks

Institutions

Contact details

Jesús Gardeazabal-García

Primary lead investigator
ORCID number:
0000-0001-5938-0835
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
National competent authority (NCAs)

More details on funding

Government institutional research programme
Study protocol
Initial protocol
English (2.43 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable