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Collecting real-world data on ovarian cancer treatment outcomes

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

Observational AstraZeneca · NCT04830709

This study is trying to understand how well different treatments work for women newly diagnosed with advanced ovarian cancer in Germany and how these treatments affect their experiences and outcomes.

Quick facts

Study typeObservational
Enrollment750 (estimated)
Ages18 Years to 130 Years
SexFemale
SponsorAstraZeneca Industry-sponsored
Drugs / interventionschemotherapy
Locations93 sites (Böblingen, Germany and 92 other locations)
Trial IDNCT04830709 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather real-world clinical and patient-reported outcomes for women newly diagnosed with advanced high-grade epithelial ovarian cancer in Germany. It focuses on the impact of first-line treatment, including surgery, chemotherapy, and maintenance therapy with PARP inhibitors, on patient outcomes and experiences. The study will also explore physician experiences, genomic testing behaviors, and treatment sequences in case of recurrence. By capturing these insights, the study seeks to inform patients, healthcare providers, and payers about the effectiveness and safety of current treatment approaches.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older who have been newly diagnosed with advanced high-grade epithelial ovarian cancer and are eligible for first-line treatment.

Not a fit: Patients with early-stage ovarian cancer or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights that improve treatment strategies and patient care for ovarian cancer.

How similar studies have performed: Other studies focusing on real-world outcomes in ovarian cancer have shown promise, indicating that this approach is both relevant and potentially impactful.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Signed written informed consent
2. Women aged ≥ 18 years
3. Newly diagnosed with primary advanced (FIGO stages III and IV) high-grade epithelial ovarian cancer (including fallopian tube and/or primary peritoneal cancer)
4. For patients who qualify for primary debulking surgery, all surgical procedures must be completed prior to enrollment
5. 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
6. 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.
7. Willing and able to report PROs electronically
8. Women of childbearing potential must use two forms of reliable contraception according to standard of care

Exclusion Criteria:

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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Where this trial is running

Böblingen, Germany and 92 other locations

+43 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ovarian CancerPatient reported outcome,advanced Ovarian Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.