Recurrent Ovarian CarcinomaNCT04369352
Register to Describe the Treatment Pattern of Platinum-sensitive Relapsed Epithelial Ovarian Cancer Patients in Austria
An observational study of Recurrent Ovarian Carcinoma, run by Medical University Innsbruck at 9 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Recurrent Ovarian Carcinoma
- How many people
- 150 participants
- Where
- 9 sitesAustria
- Study dates
- 9 Aug 2018to Aug 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients at their first platinum-sensitive ROC treated within gynecological oncology centers in Austria participating in the register.
Who may be able to join
- 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
Who cannot join
- No knowledge of spoken and written German
- Signed informed consent is not given
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Austria9 sites, 9 recruiting
- Recruiting
Medical University Graz
Graz
Edgar Petru, Prof. Dr.
- Recruiting
Medical University Innsbruck
Innsbruck
Christian Marth, Prof. Dr.
- Recruiting
Bezirkskrankenhaus Kufstein
Kufstein
Rainer Heider, Prim. Dr.
- Recruiting
LKH Hochsteiermark
Leoben
Florentia Peintinger, Prof. PD Dr.
- Recruiting
Bezirkskrankenhaus Lienz
Lienz
Birgit Volgger, Prim. Dr.
- Recruiting
Kepler Universitätsklinikum Linz
Linz
Lukas Angleitner-Boubenizek, OA Dr.
- Recruiting
Ordensklinikum Linz
Linz
Lukas Hefler, Prim. Dr.
- Recruiting
Krankenhaus der Barmherzigen Schwestern Ried
Ried im Innkreis
Florian Baminger, OA Dr.
- Recruiting
Medical University Vienna
Vienna
Alexander Reinthaller, Prof. Dr.
About this study
Official title: 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.
Read the 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
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Two years
Secondary outcomes (4)
Progression Free Survival
after first relapse and second relapse, evaluated by clinical practice in each center
Measured: 2 years per patient
Overall Survival
at 24 months
Measured: 2 years per patient
Assess Treatments
treatment duration, number of cycle, treatment exposure, time to next treatment
Measured: 2 years per patient
Overall Survival Description
died due to disease, died due to other reasons, alive
Measured: 2 years per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start9 Aug 2018
- Primary completionDec 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lukas Hefler, Prim. Dr., Principal investigator, Ordensklinikum Linz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369352
- Sponsor's protocol ID
- AGO R03 ROC
- Status last verified
- Mar 2023
- First submitted
- 27 Apr 2020
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional, Multicenter, Prospective Register Study to Describe the Treatment Pattern of Platinum-sensitive Relapsed Epithelial Ovarian Cancer (ROC) Patients in Austria
- ClinicalTrials.gov ID
- NCT04369352
- Acronym / sponsor ID
- AGO R03 ROC
- Conditions
- Recurrent Ovarian Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at their first platinum-sensitive ROC treated within gynecological oncology centers in Austria participating in the register.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- No knowledge of spoken and written German
- Signed informed consent is not given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Progression Free Survival
Time frame: 2 years per patient
Overall Survival
Time frame: 2 years per patient
Assess Treatments
Time frame: 2 years per patient
Overall Survival Description
Time frame: 2 years per patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas Hefler, Prim. Dr. principal investigator
Ordensklinikum Linz
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Ovarian Carcinoma, run by Medical University Innsbruck at 9 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AGO Studienzentrale (0043 512 504 24132, ago.studienzentrale@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.