Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588322
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Detection of Homologous Recombination Pathway Gene Mutations in Circulating Tumour DNA From BRCA-mutated Ovarian Cancer Patients Receiving First-line PARP Inhibitor Maintenance Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Detection of Homologous Recombination Pathway Gene Mutations in Circulating Tumour DNA From BRCA-mutated Ovarian Cancer Patients Receiving First-line PARP Inhibitor Maintenance Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATROVA
Brief Summary:
This is an interventional category 2 prospective multicentric cohort study designed to demonstrate that the search based on Circulating tumour DNA analysis for a BRCA12 reversion mutation leading to restoration of its protein function enables early identification of disease progression in BRCA12 mutant patients treated as first-line maintenance with a PARP inhibitor Olaparib alone or in combination with bevacizumab for ovarian cancer
For this study a total of 9 blood samples will be taken from patients who will undergo a full 24-month treatment regimen
Apart from the study procedure blood sampling all examinations carried out in this study treatment with Olaparib alone or combined with bevacizumab and patient follow-up procedures will be carried out as part of routine care in accordance with the standard practices of each investigating site
130 patients will take part in the study and each patient will be followed for 24 months
For this study a total of 9 blood samples will be taken from patients who will undergo a full 24-month treatment regimen
Apart from the study procedure blood sampling all examinations carried out in this study treatment with Olaparib alone or combined with bevacizumab and patient follow-up procedures will be carried out as part of routine care in accordance with the standard practices of each investigating site
130 patients will take part in the study and each patient will be followed for 24 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None