Evaluation of the Technical Feasibility of Testing ct DNA for Homologous Recombination Gene Variants in Metastatic Prostate Cancer.

NCT ID: NCT05415787

Last Updated: 2024-03-01

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

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-18

Study Completion Date

2024-01-18

Brief Summary

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Evaluation of technical feasibility for Homologous Recombination (HR) genes variants research on circulating tumor DNA (ctDNA) from plasma and urine of patients with a metastatic prostate cancer.

Detailed Description

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The benefit of PARPi has been well established for ovarian (SOLO-1 study) and prostate cancer (PROFOUND study) with defects in the Homologous Recombination Repair (HRR) system due to BRCA1 or BRCA2 variants. Somatic variants in HRR genes are currently researched by Next Generation Sequencing (NGS). However, in metastatic prostate cancer, using formalin-fixed and paraffin-embedded (FFPE) samples, failure rate is around 30 % according to our retrospective datas, in agreement with the data of the PROFOUND study, highlighting a real pre-analytical matter when FFPE samples are used for NGS testing. Research of such alterations on circulating tumor DNA (ctDNA) extracted from plasma or urine could be a promising alternative test.

Conditions

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Circulating Tumor DNA Metastatic Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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adult patients with metastatic prostate cancer

Blood sample

Intervention Type OTHER

2 tubes Cell free DNA are taken during a blood sample already planned in the patient's care.

Urine sample

Intervention Type OTHER

Urine sample is taken during the consultation carried out for the patient's care

Interventions

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Blood sample

2 tubes Cell free DNA are taken during a blood sample already planned in the patient's care.

Intervention Type OTHER

Urine sample

Urine sample is taken during the consultation carried out for the patient's care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Metastatic prostate cancer
* Archived tissue sample available for testing for somatic variants of HRR genes (including BRCA1/BRCA2)
* Free, informed and signed consent for research


* Refusal of blood and urine collection
* Patient cognitively incapable of signing consent to participate in this study
* Patient under guardianship or curatorship
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthias Tallegas

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Tours

Locations

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University hospital

Tours, , France

Site Status

Countries

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France

Other Identifiers

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DR220119 PROMECI

Identifier Type: -

Identifier Source: org_study_id

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