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

Last updated: April 25, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ovarian Cancer

Vaginal Cancer

Pelvic Cancer

Treatment

N/A

Clinical Study ID

NCT04830709
D0817R00030
  • Ages 18-130
  • Female

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 Criteria

Inclusion

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 epithelialovarian cancer (including fallopian tube and/or primary peritoneal cancer)

  4. For patients who qualify for primary debulking surgery, all surgical procedures mustbe completed prior to enrollment

  5. BRCA mutation test (routinely analyzed germline and/or somatic BRCA1/2 status aloneor as part of HRD status determination) already performed or initiated/intended

  6. First-line platinum-based chemotherapy planned or a maximum of 3 cycles alreadyreceived with no sign of disease progression. Total number of cycles afterenrollment should be decided individually for each single patient by the treatingphysician. In case of neoadjuvant chemotherapy and interval debulking surgery, thepatient should be enrolled after completion of surgical procedure and at the time ofthe 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 contraceptionaccording to standard of care

Exclusion

Exclusion Criteria:

  1. Pregnancy or breast-feeding 2. Current or planned participation in an interventionalclinical trial on first-line treatment of OC 3. Current or upcoming systemictreatment of any tumor other than OC 4. Not eligible for platinum-based chemotherapyor early progress during the cycles of first-line platinum-based chemotherapy priorto enrollment

Study Design

Total Participants: 750
Study Start date:
June 15, 2021
Estimated Completion Date:
March 31, 2033

Connect with a study center

  • Research Site

    Aachen, 52074
    Germany

    Active - Recruiting

  • Research Site

    Amberg, 92224
    Germany

    Active - Recruiting

  • Research Site

    Aschaffenburg, 63739
    Germany

    Active - Recruiting

  • Research Site

    Augsburg, 86156
    Germany

    Active - Recruiting

  • Research Site

    Baden-Baden, 76532
    Germany

    Active - Recruiting

  • Research Site

    Bayreuth, 95445
    Germany

    Active - Recruiting

  • Research Site

    Berlin, 14169
    Germany

    Active - Recruiting

  • Research Site

    Bielefeld, 33604
    Germany

    Active - Recruiting

  • Research Site

    Boblingen, 71032
    Germany

    Site Not Available

  • Research Site

    Bochum, 44791
    Germany

    Active - Recruiting

  • Research Site

    Boeblingen, 71032
    Germany

    Active - Recruiting

  • Research Site

    Bonn, 53113
    Germany

    Active - Recruiting

  • Research Site

    Borna, 4552
    Germany

    Active - Recruiting

  • Research Site

    Bottrop, 46236
    Germany

    Active - Recruiting

  • Research Site

    Brandenburg an der Havel, 14770
    Germany

    Active - Recruiting

  • Research Site

    Bremen, 28205
    Germany

    Active - Recruiting

  • Research Site

    Böblingen, 71032
    Germany

    Site Not Available

  • Research Site

    Coburg, 96450
    Germany

    Active - Recruiting

  • Research Site

    Donauwoerth, 86609
    Germany

    Site Not Available

  • Research Site

    Donauworth, 86609
    Germany

    Site Not Available

  • Research Site

    Donauwörth, 86609
    Germany

    Site Not Available

  • Research Site

    Dortmund, 44137
    Germany

    Active - Recruiting

  • Research Site

    Dresden, 1307
    Germany

    Active - Recruiting

  • Research Site

    Duesseldorf, 40489
    Germany

    Active - Recruiting

  • Research Site

    Dusseldorf, 40489
    Germany

    Site Not Available

  • Research Site

    Düsseldorf, 40489
    Germany

    Site Not Available

  • Research Site

    Eggenfelden, 84307
    Germany

    Active - Recruiting

  • Research Site

    Erfurt, 99084
    Germany

    Active - Recruiting

  • Research Site

    Fuerth, 90766
    Germany

    Active - Recruiting

  • Research Site

    Furth, 90766
    Germany

    Site Not Available

  • Research Site

    Fürth, 90766
    Germany

    Site Not Available

  • Research Site

    Gera, 7548
    Germany

    Active - Recruiting

  • Research Site

    Goettingen, 37075
    Germany

    Active - Recruiting

  • Research Site

    Halle, 6110
    Germany

    Active - Recruiting

  • Research Site

    Hamburg, 22457
    Germany

    Active - Recruiting

  • Research Site

    Hanau, 63450
    Germany

    Active - Recruiting

  • Research Site

    Heilbronn, 74078
    Germany

    Active - Recruiting

  • Research Site

    Hildesheim, 31134
    Germany

    Active - Recruiting

  • Research Site

    Homburg, 66421
    Germany

    Active - Recruiting

  • Research Site

    Jena, 7747
    Germany

    Active - Recruiting

  • Research Site

    Kiel, 24116
    Germany

    Active - Recruiting

  • Research Site

    Koeln, 50931
    Germany

    Active - Recruiting

  • Research Site

    Koln, 50935
    Germany

    Site Not Available

  • Research Site

    Krefeld, 47805
    Germany

    Active - Recruiting

  • Research Site

    Köln, 50935
    Germany

    Site Not Available

  • Research Site

    Leipzig, 4103
    Germany

    Active - Recruiting

  • Research Site

    Limburg, 65549
    Germany

    Active - Recruiting

  • Research Site

    Lubeck, 23562
    Germany

    Site Not Available

  • Research Site

    Luebeck, 23562
    Germany

    Active - Recruiting

  • Research Site

    Lübeck, 23562
    Germany

    Site Not Available

  • Research Site

    Magdeburg, 39108
    Germany

    Active - Recruiting

  • Research Site

    Mainz, 55131
    Germany

    Active - Recruiting

  • Research Site

    Moenchengladbach, 41061
    Germany

    Active - Recruiting

  • Research Site

    Monchengladbach, 41061
    Germany

    Site Not Available

  • Research Site

    Muenchen, 80638
    Germany

    Active - Recruiting

  • Research Site

    Muenster, 48145
    Germany

    Active - Recruiting

  • Research Site

    Munster, 48145
    Germany

    Site Not Available

  • Research Site

    Mönchengladbach, 41061
    Germany

    Site Not Available

  • Research Site

    Münster, 48145
    Germany

    Site Not Available

  • Research Site

    Nuernberg, 90419
    Germany

    Active - Recruiting

  • Research Site

    Nuertingen, 72622
    Germany

    Active - Recruiting

  • Research Site

    Nurnberg, 90419
    Germany

    Site Not Available

  • Research Site

    Nurtingen, 72622
    Germany

    Site Not Available

  • Research Site

    Nürnberg, 90419
    Germany

    Site Not Available

  • Research Site

    Nürtingen, 72622
    Germany

    Site Not Available

  • Research Site

    Offenburg, 77654
    Germany

    Active - Recruiting

  • Research Site

    Osnabruck, 49076
    Germany

    Site Not Available

  • Research Site

    Osnabrueck, 49076
    Germany

    Active - Recruiting

  • Research Site

    Osnabrück, 49076
    Germany

    Site Not Available

  • Research Site

    Pforzheim, 75179
    Germany

    Active - Recruiting

  • Research Site

    Plauen, 08525
    Germany

    Active - Recruiting

  • Research Site

    Potsdam, 14467
    Germany

    Active - Recruiting

  • Research Site

    Regensburg, 93053
    Germany

    Active - Recruiting

  • Research Site

    Rheine, 48431
    Germany

    Active - Recruiting

  • Research Site

    Rosenheim, 83022
    Germany

    Active - Recruiting

  • Research Site

    Rostock, 18059
    Germany

    Active - Recruiting

  • Research Site

    Rotenburg (W Mme), 27356
    Germany

    Active - Recruiting

  • Research Site

    Rotenburg (Wumme), 27356
    Germany

    Site Not Available

  • Research Site

    Rotenburg (Wümme), 27356
    Germany

    Site Not Available

  • Research Site

    Saarlouis, 66740
    Germany

    Active - Recruiting

  • Research Site

    Schwabisch Hall, 74523
    Germany

    Site Not Available

  • Research Site

    Schwaebisch Hall, 74523
    Germany

    Site Not Available

  • Research Site

    Schwäbisch Hall, 74523
    Germany

    Site Not Available

  • Research Site

    Siegen, 57072
    Germany

    Active - Recruiting

  • Research Site

    Singen, 78224
    Germany

    Active - Recruiting

  • Research Site

    Solingen, 42653
    Germany

    Active - Recruiting

  • Research Site

    Stendal, 39576
    Germany

    Active - Recruiting

  • Research Site

    Stralsund, 18439
    Germany

    Active - Recruiting

  • Research Site

    Stuttgart, 70199
    Germany

    Active - Recruiting

  • Research Site

    Torgau, 4860
    Germany

    Active - Recruiting

  • Research Site

    Traunstein, 83278
    Germany

    Active - Recruiting

  • Research Site

    Ulm, 89075
    Germany

    Active - Recruiting

  • Research Site

    Villingen-Schwenningen, 78052
    Germany

    Active - Recruiting

  • Research Site

    Wiesbaden, 65199
    Germany

    Active - Recruiting

  • Research Site

    Winnenden, 71364
    Germany

    Active - Recruiting

  • Research Site

    Witten, 58452
    Germany

    Active - Recruiting

  • Research Site

    Wolfsburg, 38440
    Germany

    Active - Recruiting

  • Research Site

    Worms, 67550
    Germany

    Active - Recruiting

  • Research Site

    Wuppertal, 42283
    Germany

    Active - Recruiting

  • Research Site

    Istanbul, 34349
    Turkey

    Site Not Available

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