Versatile Ampification Single-Molecule Detection in Liquid Biopsy

Melanoma (Skin) Clinical Trial

— VerSiLiB  

Official title:

Versatile Ampification Method for Single-Molecule Detection in Liquid Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05940311
• Other study ID #: RS1685/22 (2670)
• Status: Recruiting
• Start date: April 12, 2022
• Est. completion date: April 12, 2026

Study information

• Verified date: August 2022
• Source: Regina Elena Cancer Institute
• Contact: Patrizio Giacomini, MD
• Phone: +39 0652665054
• Email: patrizio.giacomini[@]ifo.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Robust detection of single molecules in complex biological fluids is the ultimate goal in the field of disease biomarker analysis.

Conventionally, to enable the quantitative analysis of individual molecules in macroscopic volumes, analyte pre-concentration and sample partitioning into fL-nL compartments has been combined with the amplification of the specific recognition events. In these setups, the positive or negative detection of fluorescence signal is triggered by enzymatic reactions occurring in each compartment.

Binary readout based on Poisson statistics quantifies ultra-low concentrations of analyte molecules. This approach has been adopted for nucleic acids analysis in current digital PCR, and is also available for proteins in a technique coined as digital ELISA.

The objective of VerSiLiB is to develop an enzyme-free amplification strategy for the analysis of both protein and nucleic acid analytes with the single digital platform that offers means to access additional information on target analytes not achievable with current technologies. Method is based on novel affinity-mediated-transport amplification, where affinity interaction of target analyte with a specific ligand attached to a magnetic nanoparticle transporter is accompanied with rapid shuttling of fluorescent tracers that serve as reporters. By applying external magnetic field, tracers are transported from the tracer storage side (where they are dark) to tracer active side (where they become bright) only if target analyte is present in the small reaction compartment. Tailored plasmonic nanostructures will be prepared at the storage and active sides of the compartment to render the tracer either dark or bright. The aim is to perform technology validation for the novel VerSiLiB proteogenomics amplification platform in cancer management using biobanked liquid biopsy samples.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 12, 2026
• Est. primary completion date: April 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• PFS < 2

• BRAF V600E Melanoma patients

• patients in adjuvant therapy

• written informed consent

Exclusion Criteria:

• overall survival < 8 weeks

Related Conditions & MeSH terms

• BRAF V600E
• Liquid Biopsy
• Melanoma
• Melanoma (Skin)
• Melanoma Stage III
• Melanoma Stage IV

Intervention

Device:
• Affinity Mediated Transport Amplification (AMT)
Rich format single-molecule detection powered by plasmotic nanostructures of the opto-fluidific chip and proteogenomics digital readout integrated into single biotech platform.

Locations

Country	Name	City	State
Italy	"Regina Elena" National Cancer Institute	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New amplification model for the detection of rare biomarkers il liquid biopsy	Analysis of rare biomarkers in advanced melanoma patients anabling simultaneous, multiplexed detection and quantification of protein and nucleic acid analytes with sensitivity at single molecular level.	3 years