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

March 27, 2023 updated by: Medical University Innsbruck

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Graz, Austria
        • Recruiting
        • Medical University Graz
        • Contact:
          • Edgar Petru, Prof. Dr.
      • Innsbruck, Austria
        • Recruiting
        • Medical University Innsbruck
        • Contact:
          • Christian Marth, Prof. Dr.
      • Kufstein, Austria
        • Recruiting
        • Bezirkskrankenhaus Kufstein
        • Contact:
          • Rainer Heider, Prim. Dr.
      • Leoben, Austria
        • Recruiting
        • LKH Hochsteiermark
        • Contact:
          • Florentia Peintinger, Prof. PD Dr.
      • Lienz, Austria
        • Recruiting
        • Bezirkskrankenhaus Lienz
        • Contact:
          • Birgit Volgger, Prim. Dr.
      • Linz, Austria
        • Recruiting
        • Kepler Universitätsklinikum Linz
        • Contact:
          • Lukas Angleitner-Boubenizek, OA Dr.
      • Linz, Austria
        • Recruiting
        • Ordensklinikum Linz
        • Contact:
          • Lukas Hefler, Prim. Dr.
      • Ried Im Innkreis, Austria
        • Recruiting
        • Krankenhaus der Barmherzigen Schwestern Ried
        • Contact:
          • Florian Baminger, OA Dr.
      • Vienna, Austria
        • Recruiting
        • Medical University Vienna
        • Contact:
          • Alexander Reinthaller, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients at their first platinum-sensitive ROC treated within gynecological oncology centers in Austria participating in the register.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
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
Time Frame: Two years
Descriptive Data Analysis
Two years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 2 years per patient
after first relapse and second relapse, evaluated by clinical practice in each center
2 years per patient
Overall Survival
Time Frame: 2 years per patient
at 24 months
2 years per patient
Assess Treatments
Time Frame: 2 years per patient
treatment duration, number of cycle, treatment exposure, time to next treatment
2 years per patient
Overall Survival Description
Time Frame: 2 years per patient
died due to disease, died due to other reasons, alive
2 years per patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University Innsbruck

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lukas Hefler, Prim. Dr., Ordensklinikum Linz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 9, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AGO R03 ROC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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