Actively Recruiting
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 BRCAHRD Testing
Led by AstraZeneca · Updated on 2026-05-22
750
Participants Needed
93
Research Sites
N/A
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
N
North-Eastern German Society of Gynecological Oncology e.V. (NOGGO e.V.)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are collecting real-world data on first-line treatment of newly diagnosed advanced high-grade epithelial ovarian cancer, including fallopian tube and primary peritoneal cancer, in Germany. This observational study aims to better understand the effects of initial treatments such as surgery, chemotherapy, and maintenance therapies, with a focus on how PARP inhibitor maintenance influences outcomes for patients, doctors, and healthcare payers. It also examines testing behaviors for BRCA and HRD mutations, treatment choices, safety, and sequences in case of cancer recurrence. The study observes three groups of patients based on their maintenance therapy after first-line platinum-based chemotherapy those receiving PARP inhibitor maintenance, those continuing bevacizumab maintenance without PARP inhibitors, and those who do not receive any maintenance treatment. Patients eligible for primary debulking surgery must have completed surgery before joining, and those undergoing neoadjuvant chemotherapy are enrolled after surgery and prior to the first post-surgery chemotherapy cycle. The study captures routine clinical care without assigning treatments. Participants will be followed for up to 84 months to record progression-free survival, recurrence, subsequent therapies, overall survival, and patient-reported quality of life using various questionnaires. Data on treatment effects, patient experiences, and physician practices will be collected during and after maintenance therapy and through recurrence. This long-term observation seeks to provide insights into treatment outcomes and patient well-being in routine medical practice.
CONDITIONS
Brief Title
Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcomes in Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Women aged 18 years or older
- Newly diagnosed with primary advanced (FIGO stages III and IV) high-grade epithelial ovarian cancer including fallopian tube and/or primary peritoneal cancer
- Completed all surgical procedures if qualified for primary debulking surgery prior to enrollment
- BRCA mutation testing performed, initiated, or intended
- Planned first-line platinum-based chemotherapy or received a maximum of 3 cycles with no sign of disease progression
- Enrollment after completion of surgery and at the time of first post-surgery chemotherapy cycle if neoadjuvant chemotherapy was given
- Willing and able to report patient-reported outcomes electronically
- Women of childbearing potential must use two reliable forms of contraception according to standard care
You will not qualify if you...
- Pregnancy or breastfeeding
- Current or planned participation in an interventional clinical trial on first-line treatment of ovarian cancer
- Current or planned systemic treatment for any tumor other than ovarian cancer
- Not eligible for platinum-based chemotherapy or early disease progression during first-line platinum-based chemotherapy prior to enrollment
Research Team
A
AstraZeneca Clinical Study Information Center
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