Detecting BRAF V600E in Blood with a CRISPR/Cas12a Lab Test
Official title: Detection of the BRAF V600E Mutation in Liquid Biopsy Using the CRISPR/Cas12a System
Run by Masaryk Memorial Cancer Institute · NCT07870265 · Data updated 2026-11-12
This study tests a blood-based test that uses CRISPR/Cas12a to detect the BRAF V600E mutation in patients with unresectable metastatic melanoma.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 17 (estimated) |
| Sponsor | Masaryk Memorial Cancer Institute Academic / other |
| Locations | 1 site (Brno, Brno) |
| Status | Recruiting |
| Started | October 20, 2026 |
| Main results expected | October 20, 2027 |
| Study ends | December 20, 2027 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07870265 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with relapsed, unresectable metastatic melanoma and known BRAF mutation status who can provide blood samples for ctDNA analysis.
✕Probably not a fit
Patients whose tumors do not shed detectable ctDNA, or whose mutation status does not align with the assay targets, may not benefit from this test.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, low-interventional study aims to develop and analytically validate a CRISPR/Cas12a–based electrochemical assay for detecting BRAF V600E in circulating tumor DNA from plasma, comparing it to established methods like NGS and ddPCR. The method combines isothermal amplification with CRISPR-mediated wild-type DNA degradation and endpoint electrochemical readout for a simple, low-cost workflow. Secondary goals include monitoring changes in mutation levels during treatment to inform potential treatment decisions. The study will enroll adults with histologically confirmed melanoma that has relapsed and is unresectable, and will involve serial blood sampling for liquid biopsy analysis.
Why it matters
Potential benefit: If successful, the test could enable earlier, less invasive monitoring of treatment response and progression, supporting personalized treatment adjustments.
How similar studies have gone: Prior studies have shown that CRISPR-based and liquid-biopsy approaches can detect mutations with high sensitivity, though this exact electrochemical CRISPR/Cas12a method for BRAF V600E in plasma is novel/early-stage.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Masaryk Memorial Cancer Institute
Brno, Brno, Czechia Recruiting
Study contacts
- Principal investigator: Radek Lakomý, Assoc. Prof., MD, Ph.D. — Masaryk Memorial Cancer Institute, Department of Comprehensive Cancer Care
- Study coordinator: Karolína Itterheimová, Mgr.
- Email: karolina.itterheimova@mou.cz
- Phone: +420 543 133 319
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.