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RECRUITING
NCT06981377

PRostate Cancer Plasma Integrative Multi-modal Evaluation

Sponsor: Santa Chiara Hospital

View on ClinicalTrials.gov

Summary

The study aims to develop PRIME (PRostate cancer plasma Integrative Multi-modal Evaluation) liquid biopsy test and to implement its use to query prospectively collected samples in advanced prostate cancer (PCa) clinical trials and/or clinical settings. In order to maximise the utility of liquid biopsies for advanced PCa, PRIME is focused on the development of novel computational and sequencing approaches that integrate multiple information from plasma circulating elements: i) cell free DNA (cfDNA) gene mutation data with accurate quantitation of cfDNA structural genomic changes, ii) cfDNA genomic profiling with cfDNA methylation status, and iii) the information provided by extracellular vesicles (EVs) and EV-associated cargo (including DNA, RNA and proteins).

Official title: Development of the PRIME Test for the Identification of Prostate Cancer Patients' Biomarkers Through Non-invasive Liquid Biopsies

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

800

Start Date

2019-05-07

Completion Date

2027-01-31

Last Updated

2025-05-20

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)

Plasma and buffy coat samples are shipped from the recruiting clinical sites to the lab of Professor Francesca Demichelis at the University of Trento (UniTN). At UniTN, samples are stored in dedicated freezers with restricted access and subsequently used as follows: * the plasma is used for the isolation of cell free DNA and extracellular vesicles (EVs); * the buffy coat is used for the extraction of genomic DNA. Nucleic acids sequencing library preparations and all downstream omics analyses are performed by Prof. Demichelis team.

Locations (4)

Istituto Romagnolo per lo Studio dei Tumori

Meldola, Forlì-Cesena, Italy

Azienda Ospedaliera San Luigi

Orbassano, Torino, Italy

Istituto Oncologico Veneto

Padova, Italy

Santa Chiara Hospital

Trento, Italy