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

NCT ID: NCT04369352

Last Updated: 2023-03-28

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-09

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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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

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Recurrent Ovarian Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Women aged 18 years or older
* Presence of first platinum-sensitive ROC (ovarian, peritoneal and/or fallopian tube cancer)
* Must have received at least 4 cycles of chemotherapy during primary therapy
* At time of inclusion a treatment for ROC must be planned
* Patients must not have more than 1 prior line of chemotherapy
* Signed informed consent

Exclusion Criteria

* No knowledge of spoken and written German
* Signed informed consent is not given
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lukas Hefler, Prim. Dr.

Role: PRINCIPAL_INVESTIGATOR

Ordensklinikum Linz

Locations

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Kepler Universitätsklinikum Linz

Linz, , Austria

Site Status RECRUITING

Ordensklinikum Linz

Linz, , Austria

Site Status RECRUITING

Medical University Graz

Graz, , Austria

Site Status RECRUITING

Medical University Innsbruck

Innsbruck, , Austria

Site Status RECRUITING

Bezirkskrankenhaus Kufstein

Kufstein, , Austria

Site Status RECRUITING

LKH Hochsteiermark

Leoben, , Austria

Site Status RECRUITING

Bezirkskrankenhaus Lienz

Lienz, , Austria

Site Status RECRUITING

Krankenhaus der Barmherzigen Schwestern Ried

Ried im Innkreis, , Austria

Site Status RECRUITING

Medical University Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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AGO Studienzentrale

Role: CONTACT

0043 512 504 24132

Facility Contacts

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Edgar Petru, Prof. Dr.

Role: primary

Christian Marth, Prof. Dr.

Role: primary

Rainer Heider, Prim. Dr.

Role: primary

Florentia Peintinger, Prof. PD Dr.

Role: primary

Birgit Volgger, Prim. Dr.

Role: primary

Lukas Angleitner-Boubenizek, OA Dr.

Role: primary

Lukas Hefler, Prim. Dr.

Role: primary

Florian Baminger, OA Dr.

Role: primary

Alexander Reinthaller, Prof. Dr.

Role: primary

Other Identifiers

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AGO R03 ROC

Identifier Type: -

Identifier Source: org_study_id

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