Clinical trial · Observational
Versatile Ampification Single-Molecule Detection in Liquid Biopsy
Versatile Ampification Method for Single-Molecule Detection in Liquid Biopsy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood plasma and circulating tumor DNA (ctDNA) | Procedure | — | UNRESOLVED |
| Blood sampling in addition to the blood normally required for their clinical management | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pilot study, descriptive statistics will be adopted (frequency, average, standard deviation, median, interval). Concordance indexes will be calculated, e.g. between dPCR and ELISA assays on the one hand and Versilib data on the other.
- timeFrame
- 48 months
- description
- Concordance will determine whether the Versilib approach is technically feasible, e.g. whether method is sound, tests meet minimal requirements (technical sensitivity, reproducibility, accuracy). False positives and false negatives will be assessed. The results of descriptive statistics will be the basis to elaborate specific hypotheses (e.g. clinical scenarios) that will be the subject of future studies.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available