Testing a New Blood Test Method for Melanoma Skin Cancer Markers
Tests a new blood method to detect melanoma markers in adults with melanoma.
Plain-language title generated from the registry record
Registry title: Versatile Ampification Single-Molecule Detection in Liquid Biopsy
Key facts
- Where
- Rome, ItalySee the site
Where in Italy
- Regina Elena National Cancer InstituteRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Regina Elena Cancer Institute
- Trial code
- NCT05940311
- Record updated
- 27 November 2024
- Original description
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.Read full original descriptionShow less
Versatile Ampification Method for Single-Molecule Detection in Liquid Biopsy
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.
Inclusion: 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: Other clinical conditions preventing blood drawing compliance, as per physician's choice; Life expectancy <8 weeks.