Real World Data Analysis of PARP Inhibitors Use in Patien... | NCT04724031

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

NCT04724031

Sponsor

Hellenic Cooperative Oncology Group

Status

Unknown status

Last Update Posted

Mar 14, 2023Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Ovarian Cancer

Interventions

PARP inhibitor

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2019Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Sep 30, 2023Estimated

First Submitted Date

Dec 17, 2020

First Submission Date that Met QC Criteria

Jan 22, 2021

First Posted Date

Jan 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2023

Last Update Posted Date

Mar 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
One cohort		women with advanced epithelial ovarian cancer who received PARP inhibitors at any line of treatment	Drug: PARP inhibitor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PARP inhibitor	Drug	use at any line of treatment in patients with advanced ovarian cancer	One cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of Progression Free Survival		12/2022

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

female with ovarian cancer

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Adamantia Nikolaidi		Athens	Attica	15321	Greece

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000067856	Poly(ADP-ribose) Polymerase Inhibitors

Ancestor Terms

ID	Term
D004791	Enzyme Inhibitors
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided