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Trial Title:
Versatile Ampification Single-Molecule Detection in Liquid Biopsy
NCT ID:
NCT05940311
Condition:
Liquid Biopsy
Melanoma (Skin)
Melanoma Stage III
Melanoma Stage IV
BRAF V600E
Conditions: Official terms:
Melanoma
Conditions: Keywords:
Biosensors
in vitro device
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Affinity Mediated Transport Amplification (AMT)
Description:
Rich format single-molecule detection powered by plasmotic nanostructures of the
opto-fluidific chip and proteogenomics digital readout integrated into single biotech
platform.
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.
Criteria for eligibility:
Study pop:
BRAF V600E Melanoma patients
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- PFS < 2
- BRAF V600E Melanoma patients
- patients in adjuvant therapy
- written informed consent
Exclusion Criteria:
- overall survival < 8 weeks
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
"Regina Elena" National Cancer Institute
Address:
City:
Rome
Zip:
00144
Country:
Italy
Status:
Recruiting
Start date:
April 12, 2022
Completion date:
April 12, 2026
Lead sponsor:
Agency:
Regina Elena Cancer Institute
Agency class:
Other
Source:
Regina Elena Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05940311
