Register to Describe the Treatment Pattern of Platinum-sensitive Relapsed Epithelial Ovarian Cancer Patients in Austria
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|ClinicalTrials.gov Identifier: NCT04369352|
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : June 9, 2020
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.
|Condition or disease|
|Recurrent Ovarian Carcinoma|
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 electroinic 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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||150 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Non-interventional, Multicenter, Prospective Register Study to Describe the Treatment Pattern of Platinum-sensitive Relapsed Epithelial Ovarian Cancer (ROC) Patients in Austria|
|Actual Study Start Date :||August 9, 2018|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2024|
- To assess treatment patterns and the reasons for selecting these treatments in patients with platinum-sensitive ROC after first relapse in Austria [ Time Frame: Two years ]Descriptive Data Analysis
- Progression Free Survival [ Time Frame: 2 years per patient ]after first relapse and second relapse, evaluated by clinical practice in each center
- Overall Survival [ Time Frame: 2 years per patient ]at 24 months
- Assess Treatments [ Time Frame: 2 years per patient ]treatment duration, number of cycle, treatment exposure, time to next treatment
- Overall Survival Description [ Time Frame: 2 years per patient ]died due to disease, died due to other reasons, alive
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369352
|Contact: AGO Studienzentrale||0043 512 504 firstname.lastname@example.org|
|Medical University Graz||Recruiting|
|Contact: Edgar Petru, Prof. Dr.|
|Medical University Innsbruck||Recruiting|
|Contact: Christian Marth, Prof. Dr.|
|Contact: Rainer Heider, Prim. Dr.|
|Contact: Florentia Peintinger, Prof. PD Dr.|
|Contact: Birgit Volgger, Prim. Dr.|
|Kepler Universitätsklinikum Linz||Recruiting|
|Contact: Lukas Angleitner-Boubenizek, OA Dr.|
|Contact: Lukas Hefler, Prim. Dr.|
|Krankenhaus der Barmherzigen Schwestern Ried||Recruiting|
|Ried Im Innkreis, Austria|
|Contact: Florian Baminger, OA Dr.|
|Medical University Vienna||Recruiting|
|Contact: Alexander Reinthaller, Prof. Dr.|
|Principal Investigator:||Lukas Hefler, Prim. Dr.||Ordensklinikum Linz|