NCT05940311Recruiting
Versatile Ampification Single-Molecule Detection in Liquid Biopsy
Versatile Ampification Method for Single-Molecule Detection in Liquid Biopsy
Source: ClinicalTrials.gov · Last updated 27 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 3 Jul 2023
- Start date
- 27 Apr 2022
- Primary completion date
- 30 Nov 2024
- Lead sponsor
- Regina Elena Cancer Institute
- Diseases
- Melanoma
- NCT number
- NCT05940311
What you commit to
- Study type: Observational
- Planned participants: 20
- From 27 Apr 2022 to the primary completion date, 30 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other clinical conditions preventing blood drawing compliance, as per physician's choice.
Other
- Life expectancy \<8 weeks
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Regina Elena National Cancer Institute Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.