Non-interventional Study to Collect Real-world Clinical and Patient-reported Outcomes in Ovarian Cancer
NCT ID: NCT04830709
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
750 participants
OBSERVATIONAL
2021-06-15
2033-03-31
Brief Summary
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* 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
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PARPi maintenance cohort (PMC)
patients who received at least one dose of PARPi as 1L MTX after 1L platinum-based CTX
No interventions assigned to this group
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 interventions assigned to this group
No maintenance cohort (NMC)
patients who never received any 1L MTX treatment (PARPi or bevacizumab)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
\-
18 Years
130 Years
FEMALE
No
Sponsors
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North-Eastern German Society of Gynecological Oncology e.V. (NOGGO e.V.)
UNKNOWN
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Böblingen, Germany, Germany
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Göttingen, Germany, Germany
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Nürtingen, Germany, Germany
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Osnabrück, Germany, Germany
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Rotenburg (Wümme), Germany, Germany
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Schwäbisch Hall, Germany, Germany
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Aachen, , Germany
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Amberg, , Germany
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Aschaffenburg, , Germany
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Augsburg, , Germany
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Baden-Baden, , Germany
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Bayreuth, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bielefeld, , Germany
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Bielefeld, , Germany
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Bochum, , Germany
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Bonn, , Germany
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Borna, , Germany
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Bottrop, , Germany
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Brandenburg, , Germany
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Bremen, , Germany
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Coburg, , Germany
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Cologne, , Germany
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Cologne, , Germany
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Dessau, , Germany
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Donauwörth, , Germany
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Dortmund, , Germany
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Dresden, , Germany
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Düsseldorf, , Germany
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Eggenfelden, , Germany
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Erfurt, , Germany
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Fürth, , Germany
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Gelnhausen, , Germany
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Gera, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hanau, , Germany
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Heilbronn, , Germany
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Hildesheim, , Germany
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Homburg, , Germany
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Itzehoe, , Germany
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Jena, , Germany
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Kiel, , Germany
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Krefeld, , Germany
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Leipzig, , Germany
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Limburg, , Germany
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Lübeck, , Germany
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Magdeburg, , Germany
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Magdeburg, , Germany
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Mainz, , Germany
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Mönchengladbach, , Germany
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München, , Germany
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Münster, , Germany
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Nuremberg, , Germany
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Offenburg, , Germany
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Pforzheim, , Germany
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Plauen, , Germany
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Potsdam, , Germany
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Recklinghausen, , Germany
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Regensburg, , Germany
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Rheine, , Germany
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Rosenheim, , Germany
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Rostock, , Germany
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Saarlouis, , Germany
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Siegen, , Germany
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Singen, , Germany
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Solingen, , Germany
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Stendal, , Germany
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Stralsund, , Germany
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Stuttgart, , Germany
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Stuttgart, , Germany
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Torgau, , Germany
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Traunstein, , Germany
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Ulm, , Germany
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Villingen-Schwenningen, , Germany
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Wiesbaden, , Germany
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Winnenden, , Germany
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Witten, , Germany
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Wolfsburg, , Germany
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Worms, , Germany
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Wuppertal, , Germany
Countries
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Central Contacts
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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
Other Identifiers
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D0817R00030
Identifier Type: -
Identifier Source: org_study_id