Status:
RECRUITING
Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcomes in Ovarian Cancer
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
North-Eastern German Society of Gynecological Oncology e.V. (NOGGO e.V.)
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-130 years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Women aged ≥ 18 years
- Newly diagnosed with primary advanced (FIGO stages III and IV) high-grade epithelial ovarian cancer (including fallopian tube and/or primary peritoneal cancer)
- For patients who qualify for primary debulking surgery, all surgical procedures must be completed prior to enrollment
- BRCA mutation test (routinely analyzed germline and/or somatic BRCA1/2 status alone or as part of HRD status determination) already performed or initiated/intended
- First-line platinum-based chemotherapy planned or a maximum of 3 cycles already received with no sign of disease progression. Total number of cycles after enrollment should be decided individually for each single patient by the treating physician. In case of neoadjuvant chemotherapy and interval debulking surgery, the patient should be enrolled after completion of surgical procedure and at the time of the 1st post-surgery cycle of platinum-based chemotherapy.
- Willing and able to report PROs electronically
- Women of childbearing potential must use two forms of reliable contraception according to standard of care
Exclusion
- 1\. Pregnancy or breast-feeding 2. Current or planned participation in an interventional clinical trial on first-line treatment of OC 3. Current or upcoming systemic treatment of any tumor other than OC 4. Not eligible for platinum-based chemotherapy or early progress during the cycles of first-line platinum-based chemotherapy prior to enrollment
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Key Trial Info
Start Date :
June 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2033
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT04830709
Start Date
June 15 2021
End Date
March 31 2033
Last Update
December 26 2025
Active Locations (92)
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1
Research Site
Böblingen, Germany, Germany, 71032
2
Research Site
Göttingen, Germany, Germany, 37075
3
Research Site
Nürtingen, Germany, Germany, 72622
4
Research Site
Osnabrück, Germany, Germany, 49076