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Versatile Ampification Single-Molecule Detection in Liquid Biopsy

NCT05940311 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2024-11-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • VTT Technical Research Centre, Finland

    collaborator OTHER

  • Institute of Health Information and Statistics of the Czech Republic

    collaborator OTHER_GOV

  • Universita degli Studi di Catania

    collaborator OTHER

  • FINNADVANCE (FIN)

    collaborator UNKNOWN

  • PDC Biotech GmbH

    collaborator INDUSTRY

  • Regina Elena Cancer Institute

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-27
Primary Completion
2024-11-30
Completion
2026-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05940311 on ClinicalTrials.gov