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Precision Medicine for L/GCMN and Melanoma 2

NCT06605443 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-02-27

No results posted yet for this 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.

Conditions

  • Melanoma (Skin Cancer)
  • Nevi and Melanomas
  • Congenital Melanocytic Nevus

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.

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    collaborator OTHER

  • Fundacion Clinic per a la Recerca Biomédica

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-09-01
Completion
2026-12-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06605443 on ClinicalTrials.gov