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RECRUITING
NCT06605443

Precision Medicine for L/GCMN and Melanoma 2

Sponsor: Fundacion Clinic per a la Recerca Biomédica

View on ClinicalTrials.gov

Summary

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.

Official title: Precision Medicine for L/GCMN and Melanoma 1 (Precis-mel 2)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-01-01

Completion Date

2026-12-01

Last Updated

2025-02-27

Healthy Volunteers

No

Interventions

DEVICE

Breath analyzer

The study subject will be advised to sit quietly for minimum 10 minutes prior the sampling to avoid temporal changes in levels of volatile organic compunds (VOCs) related to body movement or try to avoid abrupt changes in body posture. Then, he/she will be asked to blow in the breath analyzer in order to obtain the exhaled VOCs profile.

DEVICE

Skin patch

A skin patch will be placed in the anterior part of the patient's arm for the obtention of the skin VOCs profile (estimated sampling time of around 1 h). These profiles will be recorded with a dedicated software and analyzed using standard statistical methods.

GENETIC

Liquid biopsy

Circulating free tumor DNA (cfDNA) will be extracted from patient's blood and analyzed to detect mutations in BRAF and other prognostic genes.

Locations (3)

Hospital Clínic de Barcelona (Dermatology service)

Barcelona, Spain

Hospital Clínic Barcelona

Barcelona, Spain

Hospital Clínic Barcelona

Barcelona, Spain