NCT04724031

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.

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 Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

November 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

December 17, 2020

Last Update Submit

March 13, 2023

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Progression Free Survival

    12/2022

Secondary Outcomes (2)

  • Assessment of the safety profile of olaparib in women with advanced high grade ovarian cancer

    12/2021

  • Assessment of the safety profile of niraparib in women with advanced high grade ovarian cancer

    12/2021

Study Arms (1)

One cohort

women with advanced epithelial ovarian cancer who received PARP inhibitors at any line of treatment

Drug: PARP inhibitor

Interventions

PARP inhibitorDRUG

use at any line of treatment in patients with advanced ovarian cancer

One cohort

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale with ovarian cancer
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adamantia Nikolaidi

Athens, Attica, 15321, Greece

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Poly(ADP-ribose) Polymerase Inhibitors

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

Intervention Hierarchy (Ancestors)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAntineoplastic AgentsTherapeutic Uses

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2020

First Posted

January 26, 2021

Study Start

November 1, 2019

Primary Completion

June 30, 2021

Study Completion

September 30, 2023

Last Updated

March 14, 2023

Record last verified: 2023-03

Locations

GR(1)