Testing a New Blood Test Method for Melanoma Skin Cancer Markers
Tests a new blood method to detect melanoma markers in adults with melanoma.
Key facts
- Who runs it
- Regina Elena Cancer Institute
- Where
- Rome, ItalySee the site
- Trial code
- Registry title
- Versatile Ampification Single-Molecule Detection in Liquid Biopsy
- Status
- Recruiting
- People taking part
- 20 people, planned
- Started
- 27 Apr 2022
- Planned end
- 31 Mar 2026
- Type of study
- Observational
- Treatments tested
- Blood sampling in addition to the blood normally required for their clinical management
- Blood plasma and circulating tumor DNA (ctDNA)
- Record updated
- 27 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with skin melanoma that carries the BRAF p.V600E change and who can start BRAFi/MEKi treatment or immune checkpoint blockade.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Skin melanoma confirmed by cell or tissue tests. For the advanced setting, the record names stages III/IV, high risk, as typical.
- Earlier treatment
- Must be able to receive BRAFi/MEKi treatment or immune checkpoint blockade, either after surgery (adjuvant) or in advanced disease. The record also asks for PFS≤2.
- Biomarker or test result
- Tumor must be confirmed as BRAF p.V600E.
Main reasons for not taking part
- Life expectancy under 8 weeks
- Other health conditions that prevent giving blood, as the physician decides
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Other clinical conditions preventing blood drawing compliance, as per physician's choice
- Life expectancy <8 weeks
Where in Italy
- Regina Elena National Cancer InstituteRome, ItalyContact: Elena Giordani, PhDTaking people
About the trial
What the trial wants to find out
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.
Treatments tested
- Blood sampling in addition to the blood normally required for their clinical management
- Blood plasma and circulating tumor DNA (ctDNA)
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Versatile Ampification Method for Single-Molecule Detection in Liquid Biopsy
- Plain-language title
- Testing a New Blood Test Method for Melanoma Skin Cancer MarkersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 27 November 2024