Actively Recruiting
Precision Medicine for L/GCMN and Melanoma 1 (Precis-mel 2) Using Skin Patch and Breath Analyzer for Early Metastasis Detection
Led by Fundacion Clinic per a la Recerca Biomédica · Updated on 2025-02-27
100
Participants Needed
3
Research Sites
13 weeks
Total Duration
On this page
Sponsors
F
Fundacion Clinic per a la Recerca Biomédica
Lead Sponsor
H
Hospital Clinic of Barcelona
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of minimally and non-invasive technologies, such as a skin patch and a breath analyzer, to detect volatile organic compounds (VOCs) for the early identification of melanoma metastases. This prospective observational study also aims to assess how usable these devices are in monitoring high-risk melanoma patients. The study compares these methods with standard imaging techniques and liquid biopsy biomarkers for metastatic melanoma detection. Participants will undergo testing with two devices: a breath analyzer, where they will breathe into the device after sitting quietly for at least 10 minutes, and a skin patch placed on the arm for about an hour to collect skin VOCs. Additionally, blood samples will be collected for liquid biopsy to analyze tumor DNA mutations. The study will track patients with both non-metastatic and metastatic melanoma over a 24-month period. During the study, researchers will collect and analyze VOC profiles and genetic data, comparing them to current standard diagnostic and prognostic tools. Participants will be monitored regularly throughout the 24 months to assess early metastasis detection and follow-up of high-risk melanoma. The study involves non-invasive procedures and standard clinical assessments to evaluate device effectiveness and usability.
CONDITIONS
Brief Title
Precision Medicine for L/GCMN and Melanoma 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be over 18 years old
- Have a histopathological confirmed melanoma diagnosis (stage II, III or IV AJCC)
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants undergo non or minimally invasive assessments using a skin patch, breath analyzer, and liquid biopsy to collect volatile organic compounds and genetic data related to melanoma metastasis.
Regular visits for device assessments and blood sample collection over the study period
Duration - Up to 24 months
Participants are monitored to track early identification of metastases and follow-up of high-risk melanoma patients.
Visits coincide with ongoing diagnostic evaluations and standard clinical care
Trial Site Locations
Total: 3 locations
1
Hospital Clínic de Barcelona (Dermatology service)
Barcelona, Spain, 08036
Not Yet Recruiting
2
Hospital Clínic Barcelona
Barcelona, Spain
Actively Recruiting
3
Hospital Clínic Barcelona
Barcelona, Spain
Actively Recruiting
Research Team
S
Susana Puig Sardà, PhD, MD
A
Adrián López Canosa, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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