Precision Medicine for L/GCMN and Melanoma 2
- Conditions
- Melanoma (Skin Cancer)Nevi and MelanomasCongenital Melanocytic Nevus
- Interventions
- Device: Breath analyzerDevice: Skin patchGenetic: Liquid biopsy
- Registration Number
- NCT06605443
- Lead Sponsor
- Fundacion Clinic per a la Recerca Biomédica
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Be over 18 years old
- Have a histopathological confirmed melanoma diagnosis (stage II, III or IV AJCC)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Large/giant congenital melanocytic nevi Breath analyzer Patients over 18 years of age with a large/giant congenital melanocytic nevi with an estimated size of 20 cm or more. Large/giant congenital melanocytic nevi Skin patch Patients over 18 years of age with a large/giant congenital melanocytic nevi with an estimated size of 20 cm or more. Large/giant congenital melanocytic nevi Liquid biopsy Patients over 18 years of age with a large/giant congenital melanocytic nevi with an estimated size of 20 cm or more. Melanoma Breath analyzer Patients of either sex over 18 years old with histopathological confirmed melanoma. We will include patients with stage II, III or IV according to the American Joint Committee on Cancer (AJCC) staging. Melanoma Skin patch Patients of either sex over 18 years old with histopathological confirmed melanoma. We will include patients with stage II, III or IV according to the American Joint Committee on Cancer (AJCC) staging. Melanoma Liquid biopsy Patients of either sex over 18 years old with histopathological confirmed melanoma. We will include patients with stage II, III or IV according to the American Joint Committee on Cancer (AJCC) staging.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (2)
Hospital Clínic Barcelona
🇪🇸Barcelona, Spain
Hospital Clínic de Barcelona (Dermatology service)
🇪🇸Barcelona, Spain