HRD and Resistance to PAPPi in EOC Patients | NCT05310370

Studies
HRD and Resistance to PAPPi in EOC Patients

NCT05310370

Sponsor

Lei Li

Status

Unknown status

Last Update Posted

Apr 4, 2022Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Epithelial Ovarian Cancer
Homologous Recombination Deficiency
Homologous Recombination Repair Gene Mutation
Poly(ADP-ribose) Polymerase Inhibitor
Drug Resistance
Progression-free Survival
Overall Survival

Interventions

Testing of homologous recombination deficiency

Countries

China

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 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 26, 2022Actual

Primary Completion Date

Mar 26, 2024Estimated

Completion Date

Mar 26, 2025Estimated

First Submitted Date

Mar 26, 2022

First Submission Date that Met QC Criteria

Mar 26, 2022

First Posted Date

Apr 4, 2022Actual

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 26, 2022

Last Update Posted Date

Apr 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The association between homologous recombination (HR) gene mutations and homologous recombination deficiency (HRD) status in Chinese epithelial ovarian cancer (EOC) patients has been investigated in previous studies (NCT04190667 and NCT04651920). This study is to investigate the correlation between HRD and the resistance to poly(ADP-ribose) polymerase inhibitors (PARPi) in a Chinese cohort confirmed of epithelial ovarian cancer. The mutated genes, HRD score model and their relationship with the prognosis is the primary endpoint in this study. All enrolled patients will accept PARPi as maintenance therapy after the complete or partial remission of targeted lesions. A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.

Detailed Description

Not provided

Conditions Module

Conditions

Epithelial Ovarian Cancer
Homologous Recombination Deficiency
Homologous Recombination Repair Gene Mutation
Poly(ADP-ribose) Polymerase Inhibitor
Drug Resistance
Progression-free Survival
Overall Survival

Keywords

Not provided

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

Retention

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Testing of homologous recombination deficiency	Genetic	A multiple panel testing of germline and somatic genes, including BRCA1/2, and HRD score are provided for all participants.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival	Progression-free survival after the start of PARPi	One year

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	Overall survival after the start of PARPi	One year
Severe adverse events	Severe adverse events after the start of PARPi

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18 years or older
Pathological confirmation of epithelial ovarian cancer
With available tumor tissues
Given consents to participate the study
With detailed follow-up outcomes

Exclusion Criteria:

Not meeting all of the inclusion criteria
Declining to accept PARPi as maintenance therapy after the major treatment for cancer

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Chinese cohort confirmed of epithelial ovarian cancer after the complete or partial remission of disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lei Li, M.D.	Contact	86-139-1198-8831		lileigh@163.com

Overall Officials

Name	Affiliation	Role
Lei Li, M.D.	Peking Union Medical College Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lei Li	Recruiting	Beijing	Beijing Municipality	100730	China

Condition Browse Module

MeSH Terms

ID	Term
D000077216	Carcinoma, Ovarian Epithelial

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

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Browse Branches

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