Versatile Ampification Single-Molecule Detection in Liquid Biopsy
Recruiting · NCT05940311 · Observational (researchers observe without assigning treatment) · Lead sponsor: Regina Elena Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- age: ≥ 18
- PFS≤2
- Patients willing to sign an informed consent;
- Confirmed (cytologically or histologically) cutaneous melanoma diagnosis
- Confirmed BRAF p. V600E tumor status
- Eligible for BRAFi/MEKi treatment or Immune checkpoint blockade in either the adjuvant or advanced settings (the latter typically stages III/IV, high risk).
Exclusion criteria
- Life expectancy \<8 weeks
- Other clinical conditions preventing blood drawing compliance, as per physician's choice.
Where it is running
1 location listed.
- "Regina Elena" National Cancer Institute - Rome, Italy