Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC Through Liquid Biopsy Integration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Metastatic Prostate Cancer (mPC). Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC
Overview
Implementation of a new algorithm for HRR gene mutation testing in patients with mPC through liquid biopsy integration
Detailed description
Analysis of the current clinical landscape of mPC Italy to identify gaps and opportunities for improvement.
Patient identification and enrollment Blood sample collection and plasma purification ctDNA extraction and NGS analysis of homologous recombination repair (HRR) genes. Clinical Real-World Data (RWD) and molecular analysis data collection Testing algorithm development based on collected data Finalization and sharing of a best practice model for diagnostic procedures in mPC patients
Primary outcome measures
- Validation of an assay for homologous recombination repair (HRR) gene mutation testing using liquid biopsy [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Patients with metastatic prostate cancer whose tumor tissue is unavailable or inadequate for molecular testing. • Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
Exclusion criteria
- Unable to provide written informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- European Institute of oncology — Milan
Identifiers
NCT: NCT06762379 · L2-267