NCT05940311

Versatile Ampification Single-Molecule Detection in Liquid Biopsy

Versatile Ampification Method for Single-Molecule Detection in Liquid Biopsy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Blood sampling in addition to the blood normally required for their clinical management	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.
PROCEDURE	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

Timeline

• Start date: 2022-04-27
• Primary completion: 2024-11-30
• Completion: 2026-03-31
• First posted: 2023-07-11
• Last updated: 2024-11-27

Locations

1 site across 1 country: Italy