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NCT04724031 Clinical Trial

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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04724031
Other study ID # P420_PARP
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date September 30, 2023

Study information
Verified date March 2023
Source Hellenic Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Real-world clinical outcomes and toxicity data will be evaluated in patients with advanced high grade ovarian cancer who will receive PARP inhibitors.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date September 30, 2023
Est. primary completion date June 30, 2021
Accepts healthy volunteers
Gender Female
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - women >18 years old with advanced high grade ovarian cancer Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PARP inhibitor
use at any line of treatment in patients with advanced ovarian cancer

Locations
Country Name City State
Greece Adamantia Nikolaidi Athens Attiki

Sponsors (1)
Lead Sponsor Collaborator
Hellenic Cooperative Oncology Group

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of Progression Free Survival 12/2022
Secondary Assessment of the safety profile of olaparib in women with advanced high grade ovarian cancer 12/2021
Secondary Assessment of the safety profile of niraparib in women with advanced high grade ovarian cancer 12/2021
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