Evaluation of the Technical Feasibility of Testing ct DNA for Homologous Recombination Gene Variants in Metastatic Prostate Cancer.
PROMECI
1 other identifier
observational
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2022
CompletedFirst Posted
Study publicly available on registry
June 13, 2022
CompletedStudy Start
First participant enrolled
August 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2024
CompletedMarch 1, 2024
February 1, 2024
1.4 years
June 8, 2022
February 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Circulating plasma tumour DNA
search for somatic variants of HRR genes (including BRCA1/BRCA2)
Baseline
Circulating urine tumour DNA
search for somatic variants of HRR genes (including BRCA1/BRCA2)
Baseline
FFPE tissue
search for somatic variants of HRR genes (including BRCA1/BRCA2)
Baseline
Study Arms (1)
adult patients with metastatic prostate cancer
Interventions
2 tubes Cell free DNA are taken during a blood sample already planned in the patient's care.
Urine sample is taken during the consultation carried out for the patient's care
Eligibility Criteria
Patients with metastatic prostate cancer
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University hospital
Tours, 37044, France
Biospecimen
Blood sample and Urine sample
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthias Tallegas
University Hospital, Tours
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2022
First Posted
June 13, 2022
Study Start
August 18, 2022
Primary Completion
January 17, 2024
Study Completion
January 18, 2024
Last Updated
March 1, 2024
Record last verified: 2024-02