Status:
NOT_YET_RECRUITING
Gene Expression Profiles and ctDNA for Risk Stratification in Patients With Melanoma
Lead Sponsor:
European Institute of Oncology
Conditions:
Melanoma
Eligibility:
All Genders
18-99 years
Brief Summary
This study aims at assessing the role of MerlinTM and ctDNA in predicting the nodal status in patients with \>pT3b melanoma, therefore candidate for adjuvant therapy regardless of sentinel lymph node ...
Detailed Description
Cutaneous melanoma is a malignancy arising from melanocytes of the skin. Incidence rates are rising, particularly in White populations. For patients with clinically node-negative (cN0) disease, senti...
Eligibility Criteria
Inclusion
- male or female, aged at least 18 years;
- histologically documented melanoma;
- thickness \> 2 mm (\>pT3b);
- clinical node-negative (cN0) and non-metastatic (cM0) disease at ultrasound (US) and computed tomography (CT) or positron emission tomography (PET) scan;
- known BRAF, N-ras proto-oncogene (NRAS) and tyrosine-protein kinase (c-KIT) mutational status;
- candidate to SLNB;
- consent for the provision of plasma samples for ctDNA analysis and tissue samples (at a central laboratory).
Exclusion
- SLNB performed;
- receipt of neoadjuvant therapy.
Key Trial Info
Start Date :
October 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06566404
Start Date
October 30 2024
End Date
January 1 2028
Last Update
September 23 2024
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