Study for the clinical validation of a medical device for prioritising follow-up visits in patients at risk of melanoma (CVCSD_VC_2402)

Study identification

• EU PAS number:
  EUPAS1000000652
• Study ID:
  1000000652
• Official title and acronym:
  Study for the clinical validation of a medical device for prioritising follow-up visits in patients at risk of melanoma (CVCSD_VC_2402)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  With over 1.5 million new cases in 2020, skin cancers are among the world’s most prevalent malignancies. Melanoma alone accounted for roughly 325,000 of these cases, and its incidence has climbed—especially in fair‑skinned populations—due largely to increased UV exposure. ; Although melanoma risk increases with age, it remains common in younger adults.; ; In Spain, a shortage of dermatologists—just three per 100,000 inhabitants—creates lengthy waits for specialist appointments (averaging 133 days in Catalonia and 63 days at leading centres), delaying diagnosis and worsening outcomes. ; Up to 20% of GP referrals to dermatology are for benign lesions (e.g., seborrhoeic keratoses), further burdening services.; ; Teledermatology has eased some pressures but still struggles to prioritise high‑risk cases efficiently. ; Artificial intelligence offers a solution: computer‑aided diagnostic algorithms can rapidly analyse images, flagging lesions with high malignancy risk and guiding referral urgency.; ; This study evaluates Legit.Health, an AI‑driven platform that assigns urgency scores based on preliminary lesion analysis, ensuring high‑risk patients see a dermatologist sooner while low‑risk cases remain in primary care. We will assess its impact on referral prioritisation and wait‑time reduction for suspected melanoma. ; By enabling earlier detection of serious skin pathologies, Legit.Health aims to improve patient outcomes, optimise specialist resources, and reduce unnecessary consultations.
• Study status:
  Planned

Research institutions and networks

Institutions

Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau – IIB Sant Pau

AI Labs Group S.L. (Legit.Health)

Spain

Study timelines

Date when funding contract was signed

Actual:28/06/2024

Study start date

Planned:07/07/2025

Data analysis start date

Planned:01/10/2026

Date of final study report

Planned:01/11/2026

Sources of funding

Other

More details on funding

This study was conducted thanks to the Seal of Excellence under Horizon 2020 the EU's Framework Programme for Research and Innovation.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable