RecruitingNCT05940311

Versatile Ampification Single-Molecule Detection in Liquid Biopsy

Versatile Ampification Method for Single-Molecule Detection in Liquid Biopsy

Sponsor

Regina Elena Cancer Institute

Enrollment

20 participants

Start Date

Apr 27, 2022

Study Type

OBSERVATIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new liquid biopsy technique (a highly sensitive blood test) to detect and monitor melanoma cancer DNA in the bloodstream, particularly in patients with a specific BRAF gene mutation. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of skin melanoma (cutaneous melanoma) - Your tumor has been confirmed to have a BRAF V600E mutation (a specific genetic change) - You are eligible for targeted therapy (BRAF/MEK inhibitors) or immunotherapy, either as adjuvant treatment or for advanced disease - Your disease has progressed after no more than 2 prior treatments (PFS ≤ 2) **You may NOT be eligible if...** - You do not have cutaneous melanoma - Your tumor does not have the BRAF V600E mutation - You have already received extensive prior lines of treatment - You are unable to provide consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBlood 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.

PROCEDUREBlood 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