NCT04369352

Register to Describe the Treatment Pattern of Platinum-sensitive Relapsed Epithelial Ovarian Cancer Patients in Austria

Non-interventional, Multicenter, Prospective Register Study to Describe the Treatment Pattern of Platinum-sensitive Relapsed Epithelial Ovarian Cancer (ROC) Patients in Austria

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Various treatment options exist for patients with platinum-sensitive relapsed epithelial ovarian cancer (ROC). The register will provide an overview of chosen treatments including the reasons, why these options were chosen.

Detailed description

Patients at their first platinum-sensitive ROC will be invited to participate in the register. These are all patients with recurrent disease 6 or more months after the last cycle of platinum containing chemotherapy. The Observation Period will begin by signing the Informed Consent Form (ICF) and will continue for up to a total of 24 months (+/- 4 weeks) after the diagnosis of the first relapse or until patient discontinuation for any reason, or patient's death. Data on First Study Visit, Subsequent Recurrence during Observation Period and Last Observation will be collected in the electronic Case Report Form (eCRF). The register will identify symptoms and factors that led to the diagnosis, chosen therapy and the reason for choosing the therapy. At inclusion, data on general patient information, primary diagnosis, previous therapy, and tumor characteristics are collected. During the course of observation data on systemic and maintenance treatments, radiotherapies, surgeries, and outcome are documented.

Conditions

• Recurrent Ovarian Carcinoma

Timeline

• Start date: 2018-08-09
• Primary completion: 2024-12-01
• Completion: 2025-08-01
• First posted: 2020-04-30
• Last updated: 2023-03-28

Locations

9 sites across 1 country: Austria