Ignite Creation Date:
2024-05-06 @ 5:44 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05415787
Status:
COMPLETED
Last Update Posted:
2024-03-01
First Post:
2022-06-08
Brief Title:
Evaluation of the Technical Feasibility of Testing ct DNA for Homologous Recombination Gene Variants in Metastatic Prostate Cancer
Sponsor:
University Hospital Tours
Organization:
University Hospital Tours
Study Overview
Official Title:
Evaluation of the Technical Feasibility of Testing Circulating Tumour DNA for Homologous Recombination Gene Variants in Metastatic Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMECI
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None