NCT03015376

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

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
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

2 active sites

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

January 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

January 6, 2017

Last Update Submit

November 9, 2018

Conditions

Ovarian Neoplasm EpithelialHereditary Breast and Ovarian Cancer Syndrome

Keywords

epithelial ovarian cancerHereditary Breast and Ovarian Cancer Syndromenext-generation sequencingHigh-Throughput Nucleotide Sequencing

Outcome Measures

Primary Outcomes (1)

  • herited gene mutations susceptible to epithelial ovarian cancer in patients and their relatives

    two years

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

NOT YET RECRUITING

Related Publications (2)

  • 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.

    PMID: 31472684DERIVED

  • 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.

    PMID: 30759291DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum from peripheral blood and tumor tissues frome surgical samples

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer SyndromeCarcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplastic Syndromes, HereditaryOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Wu Ming, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wu Ming, MD

CONTACT

+86-13801224549drwuming@sina.com

Li Lei, MD

CONTACT

+86-13911988831lileigh@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 10, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

IPD will be shared with authorised researchers via online database.

Locations

CN(2)