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PRostate Cancer Plasma Integrative Multi-modal Evaluation

NCT06981377 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 800

Last updated 2025-05-20

No results posted yet for this study

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).

Conditions

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.

Sponsors & Collaborators

  • Università degli Studi di Trento

    collaborator OTHER

  • Santa Chiara Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-07
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06981377 on ClinicalTrials.gov