Actively Recruiting
Versatile Ampification Single-Molecule Detection in Liquid Biopsy
Led by Regina Elena Cancer Institute · Updated on 2024-11-27
20
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
Sponsors
R
Regina Elena Cancer Institute
Lead Sponsor
V
VTT Technical Research Centre, Finland
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial will test a paradigm-changing in vitro diagnostic device for Liquid Biopsy enabling facile simultaneous detection of protein and nucleic acid analytes with sensitivity at single-molecule level, e.g. not achievable with any alternative technology. A novel affinity-mediated transport amplification (AMT) method will be tested allowing for the multiplexed quantification of rare biomarkers circulating in blood. The Versilib AMT photonic biosensor will test two analytes: the known actionable DNA mutation BRAF p.V600E, and a melanoma-restricted protein antigen. The results will be compared to digital PCR and ELISA methods.
CONDITIONS
Official Title
Versatile Ampification Single-Molecule Detection in Liquid Biopsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Progression-free survival less than or equal to 2
- Patients willing to sign an informed consent
- Confirmed cutaneous melanoma diagnosis by cytology or histology
- Confirmed BRAF p.V600E tumor status
- Eligible for BRAFi/MEKi treatment or immune checkpoint blockade in adjuvant or advanced settings
You will not qualify if you...
- Life expectancy less than 8 weeks
- Any clinical conditions preventing compliance with blood drawing as decided by the physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
"Regina Elena" National Cancer Institute
Rome, Italy, 00144
Actively Recruiting
Research Team
E
Elena Giordani, PhD
CONTACT
P
Patrizio Giacomini, Doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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