Versatile Ampification Single-Molecule Detection in Liquid Biopsy

NCT05940311 | Recruiting

• 1 other identifier: RS1685/22 (2670)
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

BRAFV600E

Outcome Measures

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.

  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.

  48 months

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

BRAF V600E Melanoma patients

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• VTT Technical Research Centre, Finland: collaborator
• Institute of Health Information and Statistics of the Czech Republic: collaborator
• Universita degli Studi di Catania: collaborator
• FINNADVANCE (FIN): collaborator
• PDC Biotech GmbH: collaborator

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Blood drowing in K2EDTA vacutainer to obtain plasma

MeSH Terms

Conditions

Melanoma

Interventions

Blood Specimen Collection; Circulating Tumor DNA

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Cell-Free Nucleic Acids; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; DNA, Neoplasm; DNA

Central Study Contacts

Elena Giordani, PhD

CONTACT

+39 06 5266 2533; elena.giordani@ifo.it

Patrizio Giacomini, Doctor

CONTACT

+39 0652665054; patrizio.giacomini@guest.policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 11, 2023
• Study Start: April 27, 2022
• Primary Completion: November 30, 2024
• Study Completion: March 31, 2026
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

IT (1)