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Detection of the BRAF V600E Mutation in Liquid Biopsy Using the CRISPR/Cas12a System

RecruitingNAAges 18 Years - anyAllMasaryk Memorial Cancer Institute
NCT07870265 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years. * Subject willing and able to provide written informed consent for biological sample collection. * Ability to communicate effectively with the investigator in the local language, as well as the ability to understand and comply with study requirements. * Histologically confirmed malignant melanoma. * Radiologically or histologically confirmed disease relapse. * Feasibility/possibility of peripheral blood sampling for ctDNA analysis. * Documented, known \*BRAF\* mutation status (wild-type vs. V600E). Exclusion Criteria: * Operable disease relapse. * Age under 18 years. * Pregnant or breastfeeding women. * Patients receiving palliative care with an estimated life expectancy ≤ 3 months. * Severe alcohol and/or drug abuse during therapy. * Inability to obtain a valid biological sample for molecular analysis
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What it tests

  • Novel CRISPR/Cas12a Electrochemical Bioassay
  • Reference Standard Molecular Diagnostics (NGS and ddPCR)
  • Serial Peripheral Blood Sampling for Liquid Biopsy
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Where

1 site
Masaryk Memorial Cancer Institute
Brno, Czechia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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