Inherited Susceptible Genes Among Epithelial Ovarian Cancer | NCT03015376

Studies
Inherited Susceptible Genes Among Epithelial Ovarian Cancer

NCT03015376

Sponsor

Peking Union Medical College Hospital

Status

Unknown status

Last Update Posted

Nov 14, 2018Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Ovarian Neoplasm Epithelial
Hereditary Breast and Ovarian Cancer Syndrome

Interventions

Not provided

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

Nov 2018

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

Jan 2017

Primary Completion Date

Jan 2019Estimated

Completion Date

Jan 2019Estimated

First Submitted Date

Jan 6, 2017

First Submission Date that Met QC Criteria

Jan 6, 2017

First Posted Date

Jan 10, 2017Estimated

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

Nov 9, 2018

Last Update Posted Date

Nov 14, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lei Li, associate professor, Peking Union Medical College HospitalPrincipal Investigator

Lead Sponsor

Peking Union Medical College HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

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

Purpose: To investigate the prevalence of the germline mutations in the BRCA 1/2 and mismatch repair genes in patients with epithelial ovarian cancer (EOC) and their relatives, and related somatic mutations in tumor tissues in the northern part of china.

Patients and methods: A multicenter prospective study will be hold in the northern part of china form 2017. About 1000 female patients with epithelial ovarian cancer and their ralatives will be tested for germline mutations in the BRCA 1/2 and mismatch repair genes and related somatic mutations in tumor tissues, regardless of the family history.

Study type: Observational Official title: Prevalence study of germline mutations in susceptibility ovarian cancer genes in patients with epithelial ovarian cancer and somatic mutations in their tumor tissures in the northern part of china.

Enrollment: 1000

Detailed Description

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

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
herited gene mutations susceptible to epithelial ovarian cancer in patients and their relatives		two years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

epithelial ovarian cancer and their relatves
living in the north of Huaihe River in China
being Han Chinese

Exclusion Criteria:

non-epithelial ovarian cancer
without specific pathological diagnosis
non-Han Chinese

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patiens with epithelia ovarian cancer and their relatves in the North of China

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wu Ming, MD	Contact	+86-13801224549		drwuming@sina.com
Li Lei, MD	Contact	+86-13911988831		lileigh@163.com

Overall Officials

Name	Affiliation	Role
Wu Ming, MD	Peking Union Medical College Hospital	Principal Investigator

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31472684	Derived	Li W, Shao D, Li L, Wu M, Ma S, Tan X, Zhong S, Guo F, Wang Z, Ye M. Germline and somatic mutations of multi-gene panel in Chinese patients with epithelial ovarian cancer: a prospective cohort study. J Ovarian Res. 2019 Aug 31;12(1):80. doi: 10.1186/s13048-019-0560-y.
30759291	Derived	Li L, Ma S, Tan X, Zhong S, Wu M. The Urodynamics and Survival Outcomes of Different Methods of Dissecting the Inferior Hypogastric Plexus in Laparoscopic Nerve-Sparing Radical Hysterectomy of Type C: A Randomized Controlled Study. Ann Surg Oncol. 2019 May;26(5):1560-1568. doi: 10.1245/s10434-019-07228-8. Epub 2019 Feb 13.

ID	Term
D061325	Hereditary Breast and Ovarian Cancer Syndrome
D000077216	Carcinoma, Ovarian Epithelial

ID	Term
D001943	Breast Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010051	Ovarian Neoplasms