Versatile Ampification Single-Molecule Detection in Liquid Biopsy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRegina Elena Cancer Institute
About this trial
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
Qualifiers
age: ≥ 18
PFS≤2
Patients willing to sign an informed consent;
Confirmed (cytologically or histologically) cutaneous melanoma diagnosis
Disqualifiers
Life expectancy <8 weeks
Other clinical conditions preventing blood drawing compliance, as per physician's choice.
Trial design
Treatments tested in this trial
- Blood sampling in addition to the blood normally required for their clinical management
- Blood plasma and circulating tumor DNA (ctDNA)
Treatment groups
No treatment groups listed
Sponsors and collaborators
Regina Elena Cancer Institute
Lead sponsor
VTT Technical Research Centre, Finland
Collaborator
Institute of Health Information and Statistics of the Czech Republic
Collaborator
Universita degli Studi di Catania
Collaborator
FINNADVANCE (FIN)
Collaborator
PDC Biotech GmbH
Collaborator
Source ClinicalTrials.gov