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Detection of the BRAF V600E Mutation in Liquid Biopsy Using the CRISPR/Cas12a System
Sponsor: Masaryk Memorial Cancer Institute
Summary
The goal of this prospective, low-interventional study is to develop and optimize a highly sensitive and specific method for the detection of the BRAF V600E mutation in liquid biopsy samples from patients with unresectable metastatic melanoma after disease relapse. The method will be based on a CRISPR/Cas12a system combined with isothermal amplification and endpoint electrochemical detection using electrode chips and low-cost instrumentation.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
17
Start Date
2026-10-20
Completion Date
2027-12-20
Last Updated
2026-10-13
Healthy Volunteers
No
Interventions
Novel CRISPR/Cas12a Electrochemical Bioassay
Experimental diagnostic platform utilizing the CRISPR/Cas12a system for selective enzymatic degradation of wild-type (WT) DNA sequences, followed by isothermal nucleic acid amplification (LAMP) and end-point electrochemical signal detection on microelectrode chips. Designed for sensitive and specific detection of the BRAF V600E mutation in circulating cell-free DNA (cfDNA) isolated from plasma.
Reference Standard Molecular Diagnostics (NGS and ddPCR)
Baseline baseline characterization of tumor tissue mutation status using Next-Generation Sequencing (NGS), accompanied by droplet digital PCR (ddPCR) for orthogonal measurement and quantitation of BRAF V600E allele frequency in circulating tumor DNA (ctDNA). Serves as the reference clinical comparator for evaluating sensitivity and specificity.
Serial Peripheral Blood Sampling for Liquid Biopsy
Venipuncture collecting 10 mL of peripheral blood into dedicated blood collection tubes at two specified clinical timepoints: Day 1 (prior to treatment initiation) and Day 1 + 6 months during ongoing therapy. Collected blood samples undergo immediate plasma isolation and cfDNA extraction.
Locations (1)
Masaryk Memorial Cancer Institute
Brno, Brno, Czechia