Gene Expression Profiles and ctDNA for Risk Stratification in Patients With Melanoma
Not yet recruiting
- Conditions
- Melanoma
- Registration Number
- NCT06566404
- Lead Sponsor
- European Institute of Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Inclusion Criteria:<br><br> - male or female, aged at least 18 years;<br><br> - histologically documented melanoma;<br><br> - thickness > 2 mm (>pT3b);<br><br> - clinical node-negative (cN0) and non-metastatic (cM0) disease at ultrasound (US) and<br> computed tomography (CT) or positron emission tomography (PET) scan;<br><br> - known BRAF, NRAS and c-KIT mutational status;<br><br> - candidate to SLNB;<br><br> - consent for the provision of plasma samples for ctDNA analysis and tissue samples<br> (at a central laboratory).<br><br>Exclusion Criteria:<br><br> - SLNB performed;<br><br> - receipt of neoadjuvant therapy.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Model Performance
- Secondary Outcome Measures
Name Time Method the estimation of the association between ctDNA-positivity and SLNB-positivity;The estimation of the association between MerlinTM/ctDNA-positivity and SLNB-positivity