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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369352
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : March 28, 2023
Sponsor:
Information provided by (Responsible Party):
Medical University Innsbruck

Study Description
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Brief 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.


Condition or disease
Recurrent Ovarian Carcinoma

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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 2024
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 2 years per patient ]
    after first relapse and second relapse, evaluated by clinical practice in each center

  2. Overall Survival [ Time Frame: 2 years per patient ]
    at 24 months

  3. Assess Treatments [ Time Frame: 2 years per patient ]
    treatment duration, number of cycle, treatment exposure, time to next treatment

  4. Overall Survival Description [ Time Frame: 2 years per patient ]
    died due to disease, died due to other reasons, alive


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: AGO Studienzentrale 0043 512 504 24132 ago.studienzentrale@i-med.ac.at

Locations
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Austria
Medical University Graz Recruiting
Graz, Austria
Contact: Edgar Petru, Prof. Dr.         
Medical University Innsbruck Recruiting
Innsbruck, Austria
Contact: Christian Marth, Prof. Dr.         
Bezirkskrankenhaus Kufstein Recruiting
Kufstein, Austria
Contact: Rainer Heider, Prim. Dr.         
LKH Hochsteiermark Recruiting
Leoben, Austria
Contact: Florentia Peintinger, Prof. PD Dr.         
Bezirkskrankenhaus Lienz Recruiting
Lienz, Austria
Contact: Birgit Volgger, Prim. Dr.         
Kepler Universitätsklinikum Linz Recruiting
Linz, Austria
Contact: Lukas Angleitner-Boubenizek, OA Dr.         
Ordensklinikum Linz Recruiting
Linz, Austria
Contact: Lukas Hefler, Prim. Dr.         
Krankenhaus der Barmherzigen Schwestern Ried Recruiting
Ried Im Innkreis, Austria
Contact: Florian Baminger, OA Dr.         
Medical University Vienna Recruiting
Vienna, Austria
Contact: Alexander Reinthaller, Prof. Dr.         
Sponsors and Collaborators
Medical University Innsbruck
Investigators
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Principal Investigator: Lukas Hefler, Prim. Dr. Ordensklinikum Linz
More Information
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Responsible Party: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT04369352    
Other Study ID Numbers: AGO R03 ROC
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: March 28, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Ovarian Epithelial
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type