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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adult patients with metastatic prostate cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Other | 2 tubes Cell free DNA are taken during a blood sample already planned in the patient's care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria
Non inclusion criteria
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Patients with metastatic prostate cancer
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Tallegas | University Hospital, Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital | Tours | 37044 | France |
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Blood sample and Urine sample
| Urine sample | Other | Urine sample is taken during the consultation carried out for the patient's care |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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