Real World Data Analysis of PARP Inhibitors Use in Patients With Ovarian Cancer

March 13, 2023 updated by: Hellenic Cooperative Oncology Group
Real-world clinical outcomes and toxicity data will be evaluated in patients with advanced high grade ovarian cancer who will receive PARP inhibitors.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A prospective-retrospective analysis of patients with histologically confirmed high grade ovarian cancer who will receive or received olaparib or niraparib will be conducted at any line of treatment.

Study Type

Observational

Enrollment (Anticipated)

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 Locations

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 15321
        • Adamantia Nikolaidi

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

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

women with advanced high grade ovarian cancer who receive Parp inhibitors at any line of treatmen

Description

Inclusion Criteria:

- women >18 years old with advanced high grade ovarian cancer

Exclusion Criteria:

-

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
One cohort
women with advanced epithelial ovarian cancer who received PARP inhibitors at any line of treatment
Drug: PARP inhibitor
use at any line of treatment in patients with advanced ovarian cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of Progression Free Survival
Time Frame: 12/2022
12/2022

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of the safety profile of olaparib in women with advanced high grade ovarian cancer
Time Frame: 12/2021
12/2021
Assessment of the safety profile of niraparib in women with advanced high grade ovarian cancer
Time Frame: 12/2021
12/2021

Collaborators and Investigators

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

Sponsor

Hellenic Cooperative Oncology Group

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)

November 1, 2019

Primary Completion (Actual)

June 30, 2021

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

December 17, 2020

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P420_PARP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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