Clinical Trial

Versatile Ampification Single-Molecule Detection in Liquid Biopsy

Study acronym: VerSiLiB
Recruiting
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Record status
This record was last updated November 27, 2024 (before its estimated November 30, 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-07-03; most recent amendment 2024-11-25.
Trial Details
NCT Number NCT05940311
Lead Sponsor Regina Elena Cancer Institute
Collaborators: VTT Technical Research Centre, Finland, Institute of Health Information and Statistics of the Czech Republic, University of Catania, FINNADVANCE (FIN), PDC Biotech GmbH
Conditions Liquid Biopsy, Melanoma (Skin), Melanoma Stage III, Melanoma Stage IV
Enrollment 20 participants
Start Date 2022-04-27
Primary Completion 2024-11-30 (estimated)
Study Completion 2026-03-31 (estimated)
Updated on ClinicalTrials.gov 2024-11-27