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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| To assess treatment patterns and the reasons for selecting these treatments in patients with platinum-sensitive ROC after first relapse in Austria | Descriptive Data Analysis | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | after first relapse and second relapse, evaluated by clinical practice in each center | 2 years per patient |
| Overall Survival | at 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients at their first platinum-sensitive ROC treated within gynecological oncology centers in Austria participating in the register.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AGO Studienzentrale | Contact | 0043 512 504 24132 | ago.studienzentrale@i-med.ac.at |
| Name | Affiliation | Role |
|---|---|---|
| Lukas Hefler, Prim. Dr. | Ordensklinikum Linz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Graz | Recruiting | Graz | Austria |
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| 2 years per patient |
| Assess Treatments | treatment duration, number of cycle, treatment exposure, time to next treatment | 2 years per patient |
| Overall Survival Description | died due to disease, died due to other reasons, alive | 2 years per patient |
| Medical University Innsbruck | Recruiting | Innsbruck | Austria |
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| Bezirkskrankenhaus Kufstein | Recruiting | Kufstein | Austria |
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| LKH Hochsteiermark | Recruiting | Leoben | Austria |
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| Bezirkskrankenhaus Lienz | Recruiting | Lienz | Austria |
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| Kepler Universitätsklinikum Linz | Recruiting | Linz | Austria |
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| Ordensklinikum Linz | Recruiting | Linz | Austria |
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| Krankenhaus der Barmherzigen Schwestern Ried | Recruiting | Ried im Innkreis | Austria |
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| Medical University Vienna | Recruiting | Vienna | Austria |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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