Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04724031
Recruitment Status : Active, not recruiting
First Posted : January 26, 2021
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Hellenic Cooperative Oncology Group

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Real-world clinical outcomes and toxicity data will be evaluated in patients with advanced high grade ovarian cancer who will receive PARP inhibitors.

Condition or disease Intervention/treatment
Ovarian Cancer Drug: PARP inhibitor

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Other
Official Title: Real World Data Analysis of PARP Inhibitors Use in Patients With Ovarian Cancer
Actual Study Start Date : November 1, 2019
Actual Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Evaluation of Progression Free Survival [ Time Frame: 12/2022 ]

Secondary Outcome Measures :
  1. Assessment of the safety profile of olaparib in women with advanced high grade ovarian cancer [ Time Frame: 12/2021 ]
  2. Assessment of the safety profile of niraparib in women with advanced high grade ovarian cancer [ Time Frame: 12/2021 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female with ovarian cancer
Sampling Method:   Probability Sample
Study Population
women with advanced high grade ovarian cancer who receive Parp inhibitors at any line of treatmen
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04724031


Locations
Layout table for location information
Greece
Adamantia Nikolaidi
Athens, Attiki, Greece, 15321
Sponsors and Collaborators
Hellenic Cooperative Oncology Group
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hellenic Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT04724031    
Other Study ID Numbers: P420_PARP
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
 Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents