An observational study in Liquid Biopsy, Melanoma (Skin) and Melanoma Stage III, sponsored by Regina Elena Cancer Institute. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Regina Elena Cancer Institute · Observational
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's planned enrollment of 20 is below the median of 182 across 438 observational studies indexed under Melanoma.
Browse Melanoma studies →Regina Elena Cancer Institute is the lead sponsor of 92 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
BRAF V600E Melanoma patients
Exclusion Criteria:
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 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
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.
Time frame: 48 months
Plan to share: Undecided
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Regina Elena Cancer Institute