Liquid BiopsyVerSiLiBNCT05940311
Versatile Ampification Single-Molecule Detection in Liquid Biopsy
An observational study of Liquid Biopsy and Melanoma (Skin), run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liquid Biopsy, Melanoma (Skin), Melanoma Stage III
- What is being tested?
- Blood sampling in addition to the blood normally required for their clinical management and Blood plasma and circulating tumor DNA (ctDNA)
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 27 Apr 2022to 31 Mar 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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
Study population: BRAF V600E Melanoma patients
Who may be able to join
- 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).
Who cannot join
- Life expectancy <8 weeks
- Other clinical conditions preventing blood drawing compliance, as per physician's choice.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, 00144
Elena Giordani, PhD, +39 06 5266 2533, elena.giordani@ifo.it
Patrizio Giacomini, Doctor, patrizio.giacomini@guest.policlinicogemelli.it
About this study
Official title: Versatile Ampification Method for Single-Molecule Detection in Liquid Biopsy
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.
- Conditions
- Liquid Biopsy, Melanoma (Skin), Melanoma Stage III, Melanoma Stage IV
- Being tested
- Blood sampling in addition to the blood normally required for their clinical management, Blood plasma and circulating tumor DNA (ctDNA)
- Keywords
- BRAFV600E
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling in addition to the blood normally required for their clinical managementProcedure or surgery
Patients will undergo blood sampling in addition to the blood normally required for their clinical management. The study aims to collect 50 blood samples (one to 4) from 20 patients undergoing treatment in the adjuvant or advanced (metastatic) setting, as per standard of care. The first blood sample (T1) will be carried out immediately before the treatment, the subsequent blood samples (T2-T4) will coincide with the periodic radiographic re-evaluations, typically at months 3 and 6 (M3 and M6, T2 and T3), and at progression/recurrence, if and when recorded.
Blood plasma and circulating tumor DNA (ctDNA)Procedure or surgery
Blood drawing by venepuncture (elbow) in K2EDTA vacutainers to obtain blood plasma.The patients will otherwise receive the most appropriate treatment for their condition. The following data will be collected and pseudo-anonymised: demographic data (age and gender), histopathology including primary and metastatic sites, BRAF status, medical imaging, previous therapies assigned if any
What is being measured
The primary outcome is the main question the study is designed to answer.
Pilot study, descriptive statistics will be adopted (frequency, average, standard deviation, median, interval). Concordance indexes will be calculated, e.g. between dPCR and ELISA assays on the one hand and Versilib data on the other.
Concordance will determine whether the Versilib approach is technically feasible, e.g. whether method is sound, tests meet minimal requirements (technical sensitivity, reproducibility, accuracy). False positives and false negatives will be assessed. The results of descriptive statistics will be the basis to elaborate specific hypotheses (e.g. clinical scenarios) that will be the subject of future studies.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start27 Apr 2022
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liquid BiopsyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- VTT Technical Research Centre, Finland, Institute of Health Information and Statistics of the Czech Republic, University of Catania, FINNADVANCE (FIN), PDC Biotech GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940311
- Sponsor's protocol ID
- RS1685/22 (2670)
- Acronym
- VerSiLiB
- Status last verified
- Nov 2024
- First submitted
- 3 Jul 2023
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Versatile Ampification Method for Single-Molecule Detection in Liquid Biopsy
- ClinicalTrials.gov ID
- NCT05940311
- Acronym / sponsor ID
- VerSiLiB / RS1685/22 (2670)
- Conditions
- Liquid Biopsy, Melanoma (Skin), Melanoma Stage III, Melanoma Stage IV
- Keywords
- BRAFV600E
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- VTT Technical Research Centre, Finland, Institute of Health Information and Statistics of the Czech Republic, University of Catania, FINNADVANCE (FIN), PDC Biotech GmbH
- Study start
- 27 Apr 2022 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 11 Jul 2023 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- BRAF V600E Melanoma patients
Key inclusion criteria (6 listed)
- age: ≥ 18
- PFS≤2
- Patients willing to sign an informed consent;
- Confirmed (cytologically or histologically) cutaneous melanoma diagnosis
- Confirmed BRAF p. V600E tumor status
Key exclusion criteria (2 listed)
- Life expectancy <8 weeks
- Other clinical conditions preventing blood drawing compliance, as per physician's choice.
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 |
|---|---|---|
| Blood sampling in addition to the blood normally required for their clinical managementPatients will undergo blood sampling in addition to the blood normally required for their clinical management. The study aims to collect 50 blood samples (one to 4) from 20 patients undergoing treatment in the adjuvant or advanced (metastatic) setting, as per standard of care. The first blood sample (T1) will be carried out immediately before the treatment, the subsequent blood samples (T2-T4) will coincide with the periodic radiographic re-evaluations, typically at months 3 and 6 (M3 and M6, T2 and T3), and at progression/recurrence, if and when recorded. | Procedure or surgery | – |
| Blood plasma and circulating tumor DNA (ctDNA)Blood drawing by venepuncture (elbow) in K2EDTA vacutainers to obtain blood plasma.The patients will otherwise receive the most appropriate treatment for their condition. The following data will be collected and pseudo-anonymised: demographic data (age and gender), histopathology including primary and metastatic sites, BRAF status, medical imaging, previous therapies assigned if any | Procedure or surgery | – |
Primary outcome
Pilot study, descriptive statistics will be adopted (frequency, average, standard deviation, median, interval). Concordance indexes will be calculated, e.g. between dPCR and ELISA assays on the one hand and Versilib data on the other.
Time frame: 48 months
Concordance will determine whether the Versilib approach is technically feasible, e.g. whether method is sound, tests meet minimal requirements (technical sensitivity, reproducibility, accuracy). False positives and false negatives will be assessed. The results of descriptive statistics will be the basis to elaborate specific hypotheses (e.g. clinical scenarios) that will be the subject of future studies.
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 27 Nov 2024.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liquid Biopsy and Melanoma (Skin), run by Regina Elena Cancer Institute at 1 site in Italy.
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 6 inclusion and 2 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 27 Nov 2024. 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 Italy. 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 Elena Giordani, PhD (+39 06 5266 2533, elena.giordani@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pilot study, descriptive statistics will be adopted (frequency, average, standard deviation, median, interval). Concordance indexes will be calculated, e.g. between dPCR and ELISA assays on the one hand and Versilib data on the other. (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2024.