Versatile Ampification Single-Molecule Detection in Liquid Biopsy (VerSiLiB)

Regina Elena Cancer Institute

Status: Enrolling

Conditions: Melanoma Stage IV; Melanoma Stage III; Melanoma (Skin); Liquid Biopsy

Treatments: Procedure: Blood plasma and circulating tumor DNA (ctDNA); Procedure: Blood sampling in addition to the blood normally required for their clinical management

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05940311

RS1685/22 (2670)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.