Precision Medicine for L/GCMN and Melanoma 2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Breath analyzer, Skin patch, Liquid biopsy.
- Who it may be relevant to
- Registry conditions: Melanoma (Skin Cancer), Nevi and Melanomas, Congenital Melanocytic Nevus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Precision Medicine for L/GCMN and Melanoma 1 (Precis-mel 2)
Overview
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.
Detailed description
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.
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.
Primary outcome measures
- Early identification of metastases [Time frame: 24 months]
Secondary outcome measures (1)
- Follow-up of high-risk melanoma patients [Time frame: 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Spain · 3 centers
- Hospital Clínic de Barcelona (Dermatology service) — Barcelona
- Hospital Clínic Barcelona — Barcelona
- Hospital Clínic Barcelona — Barcelona
Identifiers
NCT: NCT06605443 · HCB/2023/1111 · HORIZON-MISS-2021-CANCER-02-03