Versatile Ampification Single-Molecule Detection in Liquid Biopsy

Recruiting now

Conditions studied: Liquid Biopsy, Melanoma (Skin), Melanoma Stage III, Melanoma Stage IV

In brief

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.

Key facts

Study ID

NCT05940311

Run by

Regina Elena Cancer Institute

People needed

20

Starts

2022-04-27

Expected to finish

2026-03-31

Last updated by the study team

2024-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Life expectancy <8 weeks
• Other clinical conditions preventing blood drawing compliance, as per physician's choice.

Where it is running

• "Regina Elena" National Cancer Institute — Rome, Italy (enrolling)

Full record on ClinicalTrials.gov

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