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Versatile Ampification Single-Molecule Detection in Liquid Biopsy

Recruitingn/aAges 18 Years - anyAllRegina Elena Cancer Institute
NCT05940311 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Blood sampling in addition to the blood normally required for their clinical management
  • Blood plasma and circulating tumor DNA (ctDNA)
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Where

1 site
"Regina Elena" National Cancer Institute
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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