Study identifier:D0817R00030
ClinicalTrials.gov identifier:NCT04830709
EudraCT identifier:N/A
CTIS identifier:N/A
Prospective non-interventional study to collect real-world clinical and patient-reported outcome data in ovarian cancer patients eligible for first-line platinum-based chemotherapy and intended for BRCA/HRD testing
ovarian cancer
N/A
No
-
Female
750
Observational
18 Years - 130 Years
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Apr 2025 by AstraZeneca
AstraZeneca
North-Eastern German Society of Gynecological Oncology e.V. (NOGGO e.V.)
This prospective non-interventional study is intended to generate new data and insights into first-line (1L) treatment of newly diagnosed advanced high-grade epithelial Ovarian cancer (OC) in Germany relevant for patients, physicians and payers. It will capture the influence of 1L Poly ADP ribose polymerase inhibitor (PARPi) maintenance treatment (MTX) on medical routine in Germany, especially on: • outcome of the 3-steps 1L treatment phase (including surgery, Chemotherapy (CTX) and MTX) including the potential of patients with primary advanced OC to be cured, • patient’s follow-up (FU) during and after MTX therapy, • patient-reported outcomes (PROs), experiences and needs, • physician’s experience, • BRCA/HRD and genomic scar testing behavior at diagnosis/during 1L therapy, • patient selection for different 1L systemic treatment approaches, • use and safety of drugs, • treatment sequence in case of recurrence
Location
Status
Location
Winnenden, Germany, Germany, 71364
Status
Recruiting
Location
Rosenheim, Germany, Germany, 83022
Status
Recruiting
Location
Traunstein, Germany, Germany, 83278
Status
Recruiting
Location
Bottrop, Germany, Germany, 46236
Status
Recruiting
Location
Homburg, Germany, Germany, 66421
Status
Recruiting
Location
Duesseldorf, Germany, Germany, 40489
Status
Recruiting
Location
Rheine, Germany, Germany, 48431
Status
Recruiting
Location
Villingen-Schwenningen, Germany, Germany, 78052
Status
Recruiting
Arms | Assigned Interventions |
---|---|
PARPi maintenance cohort (PMC) patients who received at least one dose of PARPi as 1L MTX after 1L platinum-based CTX | - |
Bevacizumab maintenance cohort (BMC) patients who continue to receive at least one dose of bevacizumab after 1L platinum-based CTX and who have not received PARPi MTX treatment | - |
No maintenance cohort (NMC) patients who never received any 1L MTX treatment (PARPi or bevacizumab) | - |
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