Versatile Ampification Single-Molecule Detection in Liquid Biopsy
NCT ID: NCT05940311
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2022-04-27
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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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.
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
Eligibility Criteria
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Inclusion Criteria
* 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
* Other clinical conditions preventing blood drawing compliance, as per physician's choice.
18 Years
ALL
No
Sponsors
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VTT Technical Research Centre, Finland
OTHER
Institute of Health Information and Statistics of the Czech Republic
OTHER_GOV
Universita degli Studi di Catania
OTHER
FINNADVANCE (FIN)
UNKNOWN
PDC Biotech GmbH
INDUSTRY
Regina Elena Cancer Institute
OTHER
Responsible Party
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Locations
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"Regina Elena" National Cancer Institute
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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RS1685/22 (2670)
Identifier Type: -
Identifier Source: org_study_id