NCT05940311 Versatile Ampification Single-Molecule Detection in Liquid Biopsy
| NCT ID | NCT05940311 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Regina Elena Cancer Institute |
| Condition | Liquid Biopsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-04-27 |
| Primary Completion | 2024-11-30 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
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.