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).
Study Type
OBSERVATIONAL
Enrollment
800
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.
Istituto Romagnolo per lo Studio dei Tumori
Meldola, Forlì-Cesena, Italy
RECRUITINGAzienda Ospedaliera San Luigi
Orbassano, Torino, Italy
RECRUITINGIstituto Oncologico Veneto
Padova, Italy
RECRUITINGSanta Chiara Hospital
Trento, Italy
RECRUITINGQuantification of circulating tumor DNA (ctDNA) in the plasma
Number of circulating tumor DNA (ctDNA) in the plasma
Time frame: From enrolment across different lines of treatment
Quantification of the fraction of cfDNA hypo/hypermethylation
Rate of cfDNA hypo/hypermethylation
Time frame: From enrolment across different lines of treatment
Presence of recurrent somatic aberrations in ctDNA (such as loss of RB1, TP53, BRCA1/2, or AR amplification).
Assessment (yes/no) of recurrent somatic aberrations in ctDNA (such as loss of RB1, TP53,
Time frame: From enrolment across different lines of treatment
Presence of Copy Number Variants (CNVs) in ctDNA
Assessment (yes/no) of Copy Number Variants (CNVs) in ctDNA
Time frame: From enrolment across different lines of treatment
Identification of EV-associated biomarkers
Assessment (yes/no) of EV-associated biomarkers
Time frame: From enrolment across different lines of treatment
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