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Recruiting NCT06981377

PRostate Cancer Plasma Integrative Multi-modal Evaluation

Trial Parameters

Condition Metastatic Prostate Cancer
Sponsor Santa Chiara Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 800
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2019-05-07
Completion 2027-01-31
Interventions
Analysis of cell free DNA, and extracellular vesicles (EVs) and EV-associated molecular components (including RNA, DNA, proteins)

Brief 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).

Eligibility Criteria

Inclusion Criteria: * Diagnosis of prostate cancer * Eligible for prostate cancer pharmacological treatment * Given consent to study participation Exclusion Criteria: \- Histological diagnosis other than prostate cancer

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