Versatile Ampification Single-Molecule Detection in Liquid Biopsy

RecruitingOBSERVATIONAL
Enrollment

20

Participants

Timeline

Start Date

April 27, 2022

Primary Completion Date

November 30, 2024

Study Completion Date

March 31, 2026

Conditions
Liquid BiopsyMelanoma (Skin)Melanoma Stage IIIMelanoma Stage IV
Interventions
PROCEDURE

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.

PROCEDURE

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

Trial Locations (1)

00144

RECRUITING

"Regina Elena National Cancer Institute", Rome

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

VTT Technical Research Centre, Finland

OTHER

collaborator

Institute of Health Information and Statistics of the Czech Republic

OTHER_GOV

collaborator

Universita degli Studi di Catania

OTHER

collaborator

FINNADVANCE (FIN)

UNKNOWN

collaborator

PDC Biotech GmbH

INDUSTRY

lead

Regina Elena Cancer Institute

OTHER