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Clinical Trials in Spain / NCT06605443
Recruiting Observational

Precision Medicine for L/GCMN and Melanoma 2

NCT06605443 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundacion Clinic per a la Recerca Biomédica
Phase
Observational
Started
2025-01-01
Last updated
2025-02-27

Condition(s) studied

Melanoma (Skin Cancer)Nevi and MelanomasCongenital Melanocytic Nevus

Investigational drug(s) / intervention(s)

Breath analyzerSkin patchLiquid biopsy

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.

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Be over 18 years old * Have a histopathological confirmed melanoma diagnosis (stage II, III or IV AJCC) Exclusion Criteria: * Not signing the informed consent form * Present other cancers or chronic diseases (such as diabetes, asthma, etc.), which may affect the volatile organic compound profiles

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Hospital Clínic de Barcelona (Dermatology service) Barcelona Spain Not Yet Recruiting
Hospital Clínic Barcelona Barcelona Spain Recruiting
Hospital Clínic Barcelona Barcelona Spain Recruiting

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Other trials for the same condition

Precision Medicine for L/GCMN and Melanoma 1 Recruiting
Neutrophil Biomarker Test for Predicting Clinical Benefit From Immunotherapy Based on Flow Cytometry Analysis Starting soon
Understanding the Transition from Normal Melanocytes to Nevus to Melanoma Recruiting
Artificial Intelligence Based Melanoma Early Diagnosis and Risk Prediction in Children, Adolescents and Young Adults Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06605443 on ClinicalTrials.gov ↗ ← All trials in Spain