Implementation of a New Algorithm for HRR Gene Mutation Testing in Patients With mPC Through Liquid Biopsy Integration

NCT ID: NCT06762379

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-20

Study Completion Date

2030-12-31

Brief Summary

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Implementation of a new algorithm for HRR gene mutation testing in patients with mPC through liquid biopsy integration

Detailed Description

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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

Conditions

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Metastatic Prostate Cancer (mPC)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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patient with metastatic prostate cancer (mPC)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

European Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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European Institute of oncology

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Elena Guerini Rocco, MD

Role: CONTACT

00390294372871

francesca lombardi, biologist

Role: CONTACT

00390257489425

Facility Contacts

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elena Guerini Rocco, MD

Role: primary

+300294372871

Other Identifiers

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L2-267

Identifier Type: -

Identifier Source: org_study_id

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