ClinicalTrialsFinder
RecruitingNCT06605443

Precision Medicine for L/GCMN and Melanoma 2

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

Sponsor

Fundacion Clinic per a la Recerca Biomédica

Enrollment

100 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

Melanoma (Skin Cancer)Nevi and MelanomasCongenital Melanocytic Nevus

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether specific chemicals released through a person's breath or skin — called volatile organic compounds (VOCs) — can serve as a non-invasive marker to help diagnose and monitor melanoma, a type of skin cancer. It also studies large birthmarks (congenital nevi) that can develop into melanoma. **You may be eligible if...** - You are 18 years or older - You have a confirmed melanoma diagnosis (stage II, III, or IV) - You are willing to sign an informed consent form **You may NOT be eligible if...** - You refuse to sign the informed consent form - You have other cancers or chronic conditions such as diabetes or asthma (which could interfere with the VOC analysis) Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Print for Your DoctorCheck Your Eligibility

Interventions

DEVICEBreath 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.

DEVICESkin 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.

GENETICLiquid 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06605443

Related Trials

Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors

NCT072879178 locations

A Study of Biological, Genetic, and Constitutional Factors and Non-invasive Monitoring to Assess Personal Cancer Risks

NCT074697091 location

A Phase II Clinical Trial on Neo-adjuvant Pembrolizumab in Patients With pT3b-T4a/b cN0M0 Melanoma.

NCT074488311 location

EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors

NCT074106761 location

Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors

NCT074104941 location