NCT05940311 Versatile Ampification Single-Molecule Detection in Liquid Biopsy
| NCT ID | NCT05940311 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Regina Elena Cancer Institute |
| Condition | Liquid Biopsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-04-27 |
| Primary Completion | 2024-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2022-04-27 with a primary completion date of 2024-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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). Exclusion Criteria: * Life expectancy \<8 weeks * Other clinical conditions preventing blood drawing compliance, as per physician's choice.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05940311 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liquid Biopsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05940311 currently recruiting?
Yes, NCT05940311 is actively recruiting participants. Contact the research team at elena.giordani@ifo.it for enrollment information.
Where is the NCT05940311 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT05940311 clinical trial?
NCT05940311 is sponsored by Regina Elena Cancer Institute. The trial plans to enroll 20 participants.