Congenital Melanocytic Nevus, Melanoma (Skin Cancer), Nevi and Melanomas
Conditions
Keywords
Volatilomics, Breath analyzer, Skin patch, Melanoma, L/GCMN, Liquid biopsy, cfDNA, Non-invasive diagnostics
Brief 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.
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
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.
Sponsors
Hospital Clinic of Barcelona
Fundacion Clinic per a la Recerca Biomédica
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early identification of metastases | 24 months | The primary objective of the study 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Follow-up of high-risk melanoma patients | 24 months | The secondary objective is to evaluate the possibility to follow-up high risk melanoma patients using minimally invasive technologies based on the detection of changes in the patterns of volatile organic compounds (VOCs). |
Countries
Spain
Contacts
Primary ContactSusana Puig Sardà, PhD, MD
Backup ContactAdrián López Canosa, PhD
Outcome results
None listed