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NCT Number: NCT05940311

Versatile Ampification Single-Molecule Detection in Liquid Biopsy

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.

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Key information

Conditions

Liquid Biopsy Melanoma Melanoma (Skin) Melanoma Stage III Melanoma Stage IV Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Life expectancy <8 weeks
  • Other clinical conditions preventing blood drawing compliance, as per physician's choice.

Treatment and study plan

Blood sampling in addition to the blood normally required for their clinical management

Procedure

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.

Blood plasma and circulating tumor DNA (ctDNA)

Procedure

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

Primary outcomes

  1. Pilot study, descriptive statistics will be adopted (frequency, average, standard deviation, median, interval). Concordance indexes will be calculated, e.g. between dPCR and ELISA assays on the one hand and Versilib data on the other.

    Time frame: 48 months

    Concordance will determine whether the Versilib approach is technically feasible, e.g. whether method is sound, tests meet minimal requirements (technical sensitivity, reproducibility, accuracy). False positives and false negatives will be assessed. The results of descriptive statistics will be the basis to elaborate specific hypotheses (e.g. clinical scenarios) that will be the subject of future studies.

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Giordani, PhD

CONTACT

[email protected]

+39 06 5266 2533

Patrizio Giacomini, Doctor

CONTACT

[email protected]

+39 0652665054

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Collaborators

  • FINNADVANCE (FIN)
  • Institute of Health Information and Statistics of the Czech Republic
  • PDC Biotech GmbH
  • University of Catania
  • VTT Technical Research Centre, Finland

Registry information

Official study title

Versatile Ampification Method for Single-Molecule Detection in Liquid Biopsy

Acronym: VerSiLiB

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Jul 11, 2023
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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