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Precision Medicine for L/GCMN and Melanoma 1 (Precis-mel 2)
The primary objective is to evaluate the possibility of using minimally and non-invasive technologies (skin patch and breath analyzer) based on the detection of volatile organic compounds (VOCs) for the early identification of metastases. The secondary objective is to evaluate the usability of these technologies in the follow up of high-risk melanoma patients.
This is a unicentric national prospective observational study aimed at evaluating the use of two devices (skin patch and breath analyzer) for the non or minimally invasive diagnosis of metastatic melanoma with a total duration of 24 months. The study will be based on the obtention of different patterns of volatile organic compounds using the aforementioned devices for melanoma patients with and without metastasis. The results will be compared with the standard procedures for the detection of metastatic melanoma (standard imaging techniques such as PET, MRI, etc.) and correlated with standard prognostic biomarkers (cfDNA mutations in BRAF, NRAS, etc.) obtained using liquid biopsy.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital Clínic de Barcelona (Dermatology service)
Barcelona, Spain
Hospital Clínic Barcelona
Barcelona, Spain
Hospital Clínic Barcelona
Barcelona, Spain
Start Date
January 1, 2025
Primary Completion Date
September 1, 2026
Completion Date
December 1, 2026
Last Updated
February 27, 2025
100
ESTIMATED participants
Breath analyzer
DEVICE
Skin patch
DEVICE
Liquid biopsy
GENETIC
Lead Sponsor
Fundacion Clinic per a la Recerca Biomédica
Collaborators
NCT06545682
NCT06934759
Data Source & Attribution
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