Unresectable Metastatic MelanomaBRAF SENSNCT07870265
Detection of the BRAF V600E Mutation in Liquid Biopsy Using the CRISPR/Cas12a System
A study testing Novel CRISPR/Cas12a Electrochemical Bioassay, Reference Standard Molecular Diagnostics (NGS and ddPCR) and Serial Peripheral Blood Sampling for Liquid Biopsy in people with Unresectable Metastatic Melanoma, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Metastatic Melanoma
- What is being tested?
- Novel CRISPR/Cas12a Electrochemical Bioassay, Reference Standard Molecular Diagnostics (NGS and ddPCR) and Serial Peripheral Blood Sampling for Liquid Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Oct 2026to 20 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Masaryk Memorial Cancer Institute
Brno, Brno, 65653
Martina Lojová, Ph.D., +420 543 136 232, martina.lojova@mou.cz
Petra Brlica Heideová, Mgr., +420 543 136 281, petra.brlicaheideova@mou.cz
About this study
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.
Read the detailed description
This prospective, low-interventional study aims to develop and analytically and clinically validate a diagnostic tool for the detection of the BRAF V600E mutation in patients with unresectable metastatic melanoma after disease relapse. The developed method is intended for potential use in personalized medicine, particularly for optimization of treatment strategies and longitudinal monitoring of treatment response and disease progression.
The diagnostic approach will be based on a CRISPR/Cas12a system combined with isothermal amplification and endpoint electrochemical detection. The CRISPR/Cas12a system will be used for selective degradation of the non-mutated (wild-type) DNA sequence, while isothermal amplification will provide a rapid and simple alternative to conventional PCR-based amplification. The amplified target will subsequently be detected using an electrochemical method based on electrode chips and relatively low-cost instrumentation.
The primary objective of the study is to develop and validate the proposed electrochemical method for the detection of the BRAF V600E mutation in circulating cell-free DNA (cfDNA) isolated from plasma. The analytical and clinical performance of the new method will be assessed by comparison with established reference methods, including next-generation sequencing (NGS) and/or digital droplet PCR (ddPCR).
Secondary objectives include evaluating changes in the presence and levels of BRAF V600E mutation in circulating DNA during treatment and assessing the potential of longitudinal changes in circulating tumor DNA (ctDNA) for early detection of disease progression or treatment resistance. The electrochemical signal obtained with the new method will be correlated with the corresponding results obtained using the reference methods. For NGS, the results will be compared with the corresponding sequencing findings, while for ddPCR, the electrochemical signal will be compared with the number of BRAF V600E-positive droplets. The sensitivity and specificity of the new electrochemical method will be evaluated in comparison with the reference methods.
Approximately 10 patients with BRAF V600E-positive unresectable metastatic melanoma will be enrolled in the study. Patients may have melanoma diagnosed at relapse or may have a newly diagnosed melanoma presenting in an unresectable metastatic stage. Approximately 5-7 patients with BRAF V600E-negative unresectable metastatic melanoma will be included as negative controls.
Peripheral blood samples will be collected at predefined time points, including before initiation of systemic treatment and after 6 months of treatment. Plasma will be isolated from the collected blood samples and used for cfDNA isolation and subsequent molecular analyses. The presence of the BRAF V600E mutation will be assessed using the newly developed electrochemical method and the established reference method(s).
Longitudinal assessment of BRAF V600E in circulating DNA will be used to evaluate changes in mutation status during treatment and to explore the potential association between changes in ctDNA levels and treatment response, disease progression, or development of treatment resistance.
- Conditions
- Unresectable Metastatic Melanoma
- Being tested
- Novel CRISPR/Cas12a Electrochemical Bioassay, Reference Standard Molecular Diagnostics (NGS and ddPCR), Serial Peripheral Blood Sampling for Liquid Biopsy
- Keywords
- BRAF V600, Metastatic melanoma, Liquid biopsy, Circulating tumor DNA (ctDNA), CRISPR/Cas12a
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel CRISPR/Cas12a Electrochemical BioassayDiagnostic test
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)Diagnostic test
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 BiopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Active Monitoring) | Experimental | BRAF V600E-Positive Metastatic Melanoma: Patients aged ≥ 18 years with histologically confirmed inoperable metastatic melanoma presenting with a documented BRAF V600E mutation (at primary diagnosis or disease relapse).
A target cohort of 10 participants will undergo serial blood sampling for longitudinal monitoring of BRAF V600E mutation dynamics in cell-free DNA (cfDNA) Receives: Diagnostic Test: Novel CRISPR/Cas12a Electrochemical Bioassay; Diagnostic Test: Reference Standard Molecular Diagnostics (NGS and ddPCR); Procedure: Serial Peripheral Blood Sampling for Liquid Biopsy |
| Arm II (Control) | Active comparator | BRAF V600E-Negative Metastatic Melanoma: Control group consisting of approximately 5 to 7 patients aged ≥ 18 years with histologically confirmed inoperable metastatic melanoma who are negative for the BRAF V600E mutation (BRAF wild-type).
Participants undergo an identical serial blood sampling protocol to evaluate background signal, analytical specificity, and diagnostic performance. Receives: Diagnostic Test: Novel CRISPR/Cas12a Electrochemical Bioassay; Diagnostic Test: Reference Standard Molecular Diagnostics (NGS and ddPCR); Procedure: Serial Peripheral Blood Sampling for Liquid Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Sensitivity and Specificity of the CRISPR/Cas12a Electrochemical Bioassay
Evaluation of the diagnostic performance (sensitivity and specificity) of the novel CRISPR/Cas12a-assisted electrochemical platform for detecting the BRAF V600E mutation in circulating cell-free DNA (cfDNA). Electrochemical current output measured on microelectrode chips will be validated against reference molecular diagnostics, specifically droplet digital PCR (ddPCR mutant allele count) and Next-Generation Sequencing (NGS).
Measured: Up to 6 months post-treatment initiation (assessed at Baseline/Day 1 and Month 6).
Secondary outcomes (3)
Longitudinal Dynamics of *BRAF* V600E ctDNA Levels During Therapy
Quantitative monitoring of longitudinal changes in BRAF V600E circulating tumor DNA (ctDNA) levels in plasma across treatment timepoints. Statistical comparison of mutant DNA level variations over time will be conducted to characterize ctDNA kinetics during therapy.
Measured: Baseline (Day 1 prior to treatment initiation) and Month 6 during treatment.
Correlation Between Electrochemical Current Signal and Reference Standard Quantitative Values
Statistical correlation between the raw electrochemical current signal (generated following Cas12a wild-type cleavage and isothermal amplification) and reference quantitative metrics, including ddPCR positive droplet count and NGS sequence variant frequency.
Measured: Baseline (Day 1) and Month 6.
Molecular Signal Evaluation for Early Disease Progression and Resistance
Qualitative and quantitative assessment of serial liquid biopsy samples to evaluate the bioassay's utility for early identification of molecular disease progression or emerging therapeutic resistance during ongoing therapy.
Measured: Up to 6 months of patient monitoring.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion20 Oct 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Unresectable Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk Memorial Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Bartošík, Ph.D., Study chair, Masaryk Memorial Cancer InstituteRadek Lakomý, Assoc. Prof., MD, Ph.D., Principal investigator, Masaryk Memorial Cancer Institute, Department of Comprehensive Cancer Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870265
- Sponsor's protocol ID
- A21/26
- Acronym
- BRAF SENS
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding the sharing of individual participant data has not yet been finalized. Formal data sharing policies for raw bioassay datasets will be determined prior to publication in accordance with institutional guidelines.
Publications
Moranova L, Stanik M, Hrstka R, Campuzano S, Bartosik M. Electrochemical LAMP-based assay for detection of RNA biomarkers in prostate cancer. Talanta. 2022 Feb 1;238(Pt 2):123064. doi: 10.1016/j.talanta.2021.123064. Epub 2021 Nov 13.
PubMed 34801892Sebuyoya R, Sevcikova S, Yusuf B, Bartosik M. Integrating isothermal amplification techniques and LNA-based AI-assisted electrochemical bioassay for analysis of KRAS G12V point mutation. Talanta. 2025 Jun 1;288:127709. doi: 10.1016/j.talanta.2025.127709. Epub 2025 Feb 7.
PubMed 39961243Izadi N, Sebuyoya R, Moranova L, Hrstka R, Anton M, Bartosik M. Electrochemical bioassay coupled to LAMP reaction for determination of high-risk HPV infection in crude lysates. Anal Chim Acta. 2021 Dec 1;1187:339145. doi: 10.1016/j.aca.2021.339145. Epub 2021 Oct 5.
PubMed 34753575Klein-Scory S, Baraniskin A, Schmiegel W, Mika T, Schroers R, Held S, Heinrich K, Tougeron D, Modest DP, Schwaner I, Eucker J, Pihusch R, Stauch M, Kaiser F, Kahl C, Karthaus M, Muller C, Burkart C, Stintzing S, Heinemann V. Evaluation of circulating tumor DNA as a prognostic and predictive biomarker in BRAF V600E mutated colorectal cancer-results from the FIRE-4.5 study. Mol Oncol. 2025 Feb;19(2):344-356. doi: 10.1002/1878-0261.13778. Epub 2024 Dec 4.
PubMed 39630848
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of the BRAF V600E Mutation in Liquid Biopsy Using the CRISPR/Cas12a System
- ClinicalTrials.gov ID
- NCT07870265
- Acronym / sponsor ID
- BRAF SENS / A21/26
- Conditions
- Unresectable Metastatic Melanoma
- Keywords
- BRAF V600, Metastatic melanoma, Liquid biopsy, Circulating tumor DNA (ctDNA), CRISPR/Cas12a
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Masaryk Memorial Cancer InstituteUniversity, hospital or other
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 20 Oct 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, low-interventional study aims to develop and analytically and clinically validate a diagnostic tool for the detection of the BRAF V600E mutation in patients with unresectable metastatic melanoma after disease relapse. The developed method is intended for potential use in personalized medicine, particularly for optimization of treatment strategies and longitudinal monitoring of treatment response and disease progression.
The diagnostic approach will be based on a CRISPR/Cas12a system combined with isothermal amplification and endpoint electrochemical detection. The CRISPR/Cas12a system will be used for selective degradation of the non-mutated (wild-type) DNA sequence, while isothermal amplification will provide a rapid and simple alternative to conventional PCR-based amplification. The amplified target will subsequently be detected using an electrochemical method based on electrode chips and relatively low-cost instrumentation.
The primary objective of the study is to develop and validate the proposed electrochemical method for the detection of the BRAF V600E mutation in circulating cell-free DNA (cfDNA) isolated from plasma. The analytical and clinical performance of the new method will be assessed by comparison with established reference methods, including next-generation sequencing (NGS) and/or digital droplet PCR (ddPCR).
Secondary objectives include evaluating changes in the presence and levels of BRAF V600E mutation in circulating DNA during treatment and assessing the potential of longitudinal changes in circulating tumor DNA (ctDNA) for early detection of disease progression or treatment resistance. The electrochemical signal obtained with the new method will be correlated with the corresponding results obtained using the reference methods. For NGS, the results will be compared with the corresponding sequencing findings, while for ddPCR, the electrochemical signal will be compared with the number of BRAF V600E-positive droplets. The sensitivity and specificity of the new electrochemical method will be evaluated in comparison with the reference methods.
Approximately 10 patients with BRAF V600E-positive unresectable metastatic melanoma will be enrolled in the study. Patients may have melanoma diagnosed at relapse or may have a newly diagnosed melanoma presenting in an unresectable metastatic stage. Approximately 5-7 patients with BRAF V600E-negative unresectable metastatic melanoma will be included as negative controls.
Peripheral blood samples will be collected at predefined time points, including before initiation of systemic treatment and after 6 months of treatment. Plasma will be isolated from the collected blood samples and used for cfDNA isolation and subsequent molecular analyses. The presence of the BRAF V600E mutation will be assessed using the newly developed electrochemical method and the established reference method(s).
Longitudinal assessment of BRAF V600E in circulating DNA will be used to evaluate changes in mutation status during treatment and to explore the potential association between changes in ctDNA levels and treatment response, disease progression, or development of treatment resistance.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Active Monitoring) | Experimental | Diagnostic Test: Novel CRISPR/Cas12a Electrochemical Bioassay, Diagnostic Test: Reference Standard Molecular Diagnostics (NGS and ddPCR), Procedure: Serial Peripheral Blood Sampling for Liquid BiopsyBRAF V600E-Positive Metastatic Melanoma: Patients aged ≥ 18 years with histologically confirmed inoperable metastatic melanoma presenting with a documented BRAF V600E mutation (at primary diagnosis or disease relapse). A target cohort of 10 participants will undergo serial blood sampling for longitudinal monitoring of BRAF V600E mutation dynamics in cell-free DNA (cfDNA) |
| Arm II (Control) | Active comparator | Diagnostic Test: Novel CRISPR/Cas12a Electrochemical Bioassay, Diagnostic Test: Reference Standard Molecular Diagnostics (NGS and ddPCR), Procedure: Serial Peripheral Blood Sampling for Liquid BiopsyBRAF V600E-Negative Metastatic Melanoma: Control group consisting of approximately 5 to 7 patients aged ≥ 18 years with histologically confirmed inoperable metastatic melanoma who are negative for the BRAF V600E mutation (BRAF wild-type). Participants undergo an identical serial blood sampling protocol to evaluate background signal, analytical specificity, and diagnostic performance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel CRISPR/Cas12a Electrochemical BioassayExperimental 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. | Diagnostic test | Arm I (Active Monitoring), Arm II (Control) |
| 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. | Diagnostic test | Arm I (Active Monitoring), Arm II (Control) |
| Serial Peripheral Blood Sampling for Liquid BiopsyVenipuncture 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. | Procedure or surgery | Arm I (Active Monitoring), Arm II (Control) |
Primary outcome
Diagnostic Sensitivity and Specificity of the CRISPR/Cas12a Electrochemical Bioassay
Time frame: Up to 6 months post-treatment initiation (assessed at Baseline/Day 1 and Month 6).
Evaluation of the diagnostic performance (sensitivity and specificity) of the novel CRISPR/Cas12a-assisted electrochemical platform for detecting the BRAF V600E mutation in circulating cell-free DNA (cfDNA). Electrochemical current output measured on microelectrode chips will be validated against reference molecular diagnostics, specifically droplet digital PCR (ddPCR mutant allele count) and Next-Generation Sequencing (NGS).
3 secondary outcomes
Longitudinal Dynamics of *BRAF* V600E ctDNA Levels During Therapy
Time frame: Baseline (Day 1 prior to treatment initiation) and Month 6 during treatment.
Correlation Between Electrochemical Current Signal and Reference Standard Quantitative Values
Time frame: Baseline (Day 1) and Month 6.
Molecular Signal Evaluation for Early Disease Progression and Resistance
Time frame: Up to 6 months of patient monitoring.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 34801892Moranova L, Stanik M, Hrstka R, Campuzano S, Bartosik M. Electrochemical LAMP-based assay for detection of RNA biomarkers in prostate cancer. Talanta. 2022 Feb 1;238(Pt 2):123064. doi: 10.1016/j.talanta.2021.123064. Epub 2021 Nov 13.
- Background: PubMed 39961243Sebuyoya R, Sevcikova S, Yusuf B, Bartosik M. Integrating isothermal amplification techniques and LNA-based AI-assisted electrochemical bioassay for analysis of KRAS G12V point mutation. Talanta. 2025 Jun 1;288:127709. doi: 10.1016/j.talanta.2025.127709. Epub 2025 Feb 7.
- Background: PubMed 34753575Izadi N, Sebuyoya R, Moranova L, Hrstka R, Anton M, Bartosik M. Electrochemical bioassay coupled to LAMP reaction for determination of high-risk HPV infection in crude lysates. Anal Chim Acta. 2021 Dec 1;1187:339145. doi: 10.1016/j.aca.2021.339145. Epub 2021 Oct 5.
- Background: PubMed 39630848Klein-Scory S, Baraniskin A, Schmiegel W, Mika T, Schroers R, Held S, Heinrich K, Tougeron D, Modest DP, Schwaner I, Eucker J, Pihusch R, Stauch M, Kaiser F, Kahl C, Karthaus M, Muller C, Burkart C, Stintzing S, Heinemann V. Evaluation of circulating tumor DNA as a prognostic and predictive biomarker in BRAF V600E mutated colorectal cancer-results from the FIRE-4.5 study. Mol Oncol. 2025 Feb;19(2):344-356. doi: 10.1002/1878-0261.13778. Epub 2024 Dec 4.
- Individual participant dataSharing planned: Undecided. A decision regarding the sharing of individual participant data has not yet been finalized. Formal data sharing policies for raw bioassay datasets will be determined prior to publication in accordance with institutional guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Bartošík, Ph.D. study chair
Masaryk Memorial Cancer Institute
Radek Lakomý, Assoc. Prof., MD, Ph.D. principal investigator
Masaryk Memorial Cancer Institute, Department of Comprehensive Cancer Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel CRISPR/Cas12a Electrochemical Bioassay, Reference Standard Molecular Diagnostics (NGS and ddPCR) and Serial Peripheral Blood Sampling for Liquid Biopsy in people with Unresectable Metastatic Melanoma, run by Masaryk Memorial Cancer Institute at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karolína Itterheimová, Mgr. (+420 543 133 319, karolina.itterheimova@mou.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Sensitivity and Specificity of the CRISPR/Cas12a Electrochemical Bioassay (time frame: Up to 6 months post-treatment initiation (assessed at Baseline/Day 1 and Month 6).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07870265, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.