NCT04369352

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

6.3 years

First QC Date

April 27, 2020

Last Update Submit

March 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Progression Free Survival

    2 years per patient

  • Overall Survival

    2 years per patient

  • Assess Treatments

    2 years per patient

  • Overall Survival Description

    2 years per patient

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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
  • Patients must not have more than 1 prior line of chemotherapy
  • Signed informed consent

You may not qualify if:

  • No knowledge of spoken and written German
  • Signed informed consent is not given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Medical University Graz

Graz, Austria

RECRUITING

Medical University Innsbruck

Innsbruck, Austria

RECRUITING

Bezirkskrankenhaus Kufstein

Kufstein, Austria

RECRUITING

LKH Hochsteiermark

Leoben, Austria

RECRUITING

Bezirkskrankenhaus Lienz

Lienz, Austria

RECRUITING

Kepler Universitätsklinikum Linz

Linz, Austria

RECRUITING

Ordensklinikum Linz

Linz, Austria

RECRUITING

Krankenhaus der Barmherzigen Schwestern Ried

Ried im Innkreis, Austria

RECRUITING

Medical University Vienna

Vienna, Austria

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Lukas Hefler, Prim. Dr.

    Ordensklinikum Linz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2020

First Posted

April 30, 2020

Study Start

August 9, 2018

Primary Completion

December 1, 2024

Study Completion

August 1, 2025

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations