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

Fundacion Clinic per a la Recerca Biomédica

Status: Enrolling

Conditions: Nevi and Melanomas; Congenital Melanocytic Nevus; Melanoma (Skin Cancer)

Treatments: Device: Breath analyzer; Genetic: Liquid biopsy; Device: Skin patch

Study type: Observational

Funder types: Other

Identifiers

NCT06605443

HCB/2023/1111

HORIZON-MISS-2021-CANCER-02-03 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Melanoma (non-metastatic)

Description:

Patients of either sex over 18 years old with histopathological confirmed melanoma in a non metastatic stage (I to IIb stages according to AJCC classification)

Treatment:

Device: Skin patch

Genetic: Liquid biopsy

Device: Breath analyzer

Melanoma (metastatic)

Description:

Patients of either sex over 18 years old with histopathological confirmed melanoma in a metastatic stage (IIIa to IV stages according to AJCC classification)