Versatile Ampification Single-Molecule Detection in Liquid Biopsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sampling in addition to the blood normally required for their clinical management, Blood plasma and circulating tumor DNA (ctDNA).
- Who it may be relevant to
- Registry conditions: Liquid Biopsy, Melanoma (Skin), Melanoma Stage III, Melanoma Stage IV. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Versatile Ampification Method for Single-Molecule Detection in Liquid Biopsy
Overview
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.
Interventions
- Procedure Blood sampling in addition to the blood normally required for their clinical management
Patients will undergo blood sampling in addition to the blood normally required for their clinical management. The study aims to collect 50 blood samples (one to 4) from 20 patients undergoing treatment in the adjuvant or advanced (metastatic) setting, as per standard of care. The first blood sample (T1) will be carried out immediately before the treatment, the subsequent blood samples (T2-T4) will coincide with the periodic radiographic re-evaluations, typically at months 3 and 6 (M3 and M6, T2 - Procedure Blood plasma and circulating tumor DNA (ctDNA)
Blood drawing by venepuncture (elbow) in K2EDTA vacutainers to obtain blood plasma.The patients will otherwise receive the most appropriate treatment for their condition. The following data will be collected and pseudo-anonymised: demographic data (age and gender), histopathology including primary and metastatic sites, BRAF status, medical imaging, previous therapies assigned if any
Primary outcome measures
- 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. [Time frame: 48 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- "Regina Elena" National Cancer Institute — Rome
Identifiers
NCT: NCT05940311 · RS1685/22 (2670)