Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcomes in Ovarian Cancer

NCT04830709 · tracked via the Priya Life Science Germany tracker

Sponsor

AstraZeneca

Phase

Observational

Started

2021-06-15

Last updated

2026-07-10

Condition(s) studied

Ovarian Cancer

Study 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 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

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

130 Years

Healthy volunteers

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 \-

Primary outcome measure(s)

progression-free survival (PFS) — date of 1st dose of 1L platinum-based CTX to disease progression (investigator-assessed according to clinical routine) or death of any cause, whichever came first, assessed up to 84 months
The primary outcome is progression-free survival (PFS) defined as time from 1st dose of 1L platinum-based CTX to disease progression (investigator-assessed according to clinical routine) or death of any cause. Methods and intervals for tumor assessments are at the discretion of the treating physician. Details on progression incl. the procedure used to confirm progression (e.g. symptoms, ultrasound, x-ray, CT, MRI) will be captured in the eCRF.

Trial sites (89)

Facility	City	Region
Research Site	Böblingen	Germany
Research Site	Göttingen	Germany
Research Site	Nürtingen	Germany
Research Site	Osnabrück	Germany
Research Site	Rotenburg (Wümme)	Germany
Research Site	Aachen	Germany
Research Site	Amberg	Germany
Research Site	Aschaffenburg	Germany
Research Site	Augsburg	Germany
Research Site	Bayreuth	Germany
Research Site	Berlin	Germany
Research Site	Berlin	Germany
Research Site	Berlin	Germany
Research Site	Berlin	Germany
Research Site	Berlin	Germany
Research Site	Berlin	Germany
Research Site	Berlin	Germany
Research Site	Berlin	Germany
Research Site	Berlin	Germany
Research Site	Bielefeld	Germany
Research Site	Bielefeld	Germany
Research Site	Bochum	Germany
Research Site	Bonn	Germany
Research Site	Borna	Germany
Research Site	Bottrop	Germany
Research Site	Brandenburg an der Havel	Germany
Research Site	Bremen	Germany
Research Site	Coburg	Germany
Research Site	Cologne	Germany
Research Site	Cologne	Germany
Research Site	Dessau	Germany
Research Site	Dortmund	Germany
Research Site	Dresden	Germany
Research Site	Düsseldorf	Germany
Research Site	Eggenfelden	Germany
Research Site	Erfurt	Germany
Research Site	Fürth	Germany
Research Site	Gelnhausen	Germany
Research Site	Gera	Germany
Research Site	Halle	Germany

+ 49 more sites — see the full list on the official registry below.

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Other trials for the same condition

Trial on Radical Upfront Surgery in Advanced Ovarian Cancer Active, not recruiting

Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors Recruiting

FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC Recruiting

Updating the EORTC Quality-of-Life Questionnaire for Ovarian Cancer (QLQ-OV38) Starting soon

Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04830709 on ClinicalTrials.gov ↗ ← All trials in Germany