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Inherited Susceptible Genes Among Epithelial Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03015376
Recruitment Status : Recruiting
First Posted : January 10, 2017
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

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


Condition or disease
Ovarian Neoplasm Epithelial Hereditary Breast and Ovarian Cancer Syndrome

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Study on Characters and Distribution of Inherited Susceptible Genes Among Epithelial Ovarian Cancer Patients and Their Relatives in the North of China
Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019





Primary Outcome Measures :
  1. herited gene mutations susceptible to epithelial ovarian cancer in patients and their relatives [ Time Frame: two years ]

Biospecimen Retention:   Samples With DNA
serum from peripheral blood and tumor tissues frome surgical samples


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patiens with epithelia ovarian cancer and their relatves in the North of China
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. non-epithelial ovarian cancer
  2. without specific pathological diagnosis
  3. non-Han Chinese

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015376


Contacts
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Contact: Wu Ming, MD +86-13801224549 drwuming@sina.com
Contact: Li Lei, MD +86-13911988831 lileigh@163.com

Locations
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China, Beijing
Lei Li Recruiting
Beijing, Beijing, China, 100730
Contact: Lei Li, MD    008613911988831    lileigh@163.com   
Peking Union Medical College Hospital Not yet recruiting
Beijing, Beijing, China, 100730
Contact: Wu Ming, MD    +86-13801224549    drwuming@sina.com   
Contact: Li Lei, MD    +86-13911988831    lileigh@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Wu Ming, MD Peking Union Medical College Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lei Li, associate professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03015376     History of Changes
Other Study ID Numbers: EOC-GENE
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared with authorised researchers via online database.
Keywords provided by Lei Li, Peking Union Medical College Hospital:
epithelial ovarian cancer
Hereditary Breast and Ovarian Cancer Syndrome
next-generation sequencing
High-Throughput Nucleotide Sequencing
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Hereditary Breast and Ovarian Cancer Syndrome
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Breast Neoplasms
Neoplastic Syndromes, Hereditary
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Genetic Diseases, Inborn
Breast Diseases
Skin Diseases