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Trial record 2 of 579 for:    RS Oncology
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Genotyping 2 SNPs in Chinese Breast Cancers

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ClinicalTrials.gov Identifier: NCT02886845
Recruitment Status : Unknown
Verified January 2022 by Song Hongping, The First Affiliated Hospital of the Fourth Military Medical University.
Recruitment status was:  Recruiting
First Posted : September 1, 2016
Last Update Posted : January 14, 2022
Sponsor:
Information provided by (Responsible Party):
Song Hongping, The First Affiliated Hospital of the Fourth Military Medical University

Study Description
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Brief Summary:
The purpose of this study is to determine the frequency of two Single Nucleotide Polymorphisms (SNPs) by sanger-sequencing in Breast Cancers and healthy controls .

Condition or disease Intervention/treatment
rs185670819 and rs183489969 Genetic: rs183489969,rs185670819

Detailed Description:

Since the 1990s breast cancers incidence of china has increased more than twice as fast as global rates. Chinese patients are responsible for 12.2% of all newly diagnosed breast cancers and 9.6% of all deaths to world breast cancers. Breast cancer is now the second frequently diagnosed cancer and is the leading cause of cancer-related death in Chinese women.

Two of the most prevalent breast cancer susceptibility genes are BRCA1and BRCA2. However，because of population based Genetic heterogeneity, the frequency of BRCA1/BRCA2 mutation is not as high in Caucasian population as in China. Anyway, the mean age at diagnosis of breast cancer in China is almost 10 years younger and more cases are diagnosed before 40 than those in Caucasians. Therefore, it is believed that there are certain specific susceptibility loci in Chinese breast cancers.

In preliminary experiments, investigators found two germline mutations may associate with Chinese breast cancers.

The purpose of the study is to determine the frequency of two germline mutations by sanger-sequencing in a larger sample of Chinese breast cancers

Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study of Two Single Nucleotide Polymorphisms in Chinese Breast Cancers
Study Start Date : August 2016
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Chinese Breast Cancers
Woman with breast cancer that have been diagnosed in clinic
 Genetic: rs183489969,rs185670819
compare the frequency of two germline mutations in breast cancers and controls
healthy controls
Woman without breast cancer
 Genetic: rs183489969,rs185670819
compare the frequency of two germline mutations in breast cancers and controls


Outcome Measures
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Primary Outcome Measures :
  1. Genotyping of 2 SNPs ( rs185670819 and rs183489969) in Chinese breast cancer patients and age-matched healthy control women . [ Time Frame: January of 2019 ]

Secondary Outcome Measures :
  1. Both of the 2 SNPs' minor allele frequency or affected ratio shows statistically significant differences between case and control groups [ Time Frame: June of 2019 ]

Biospecimen Retention:   Samples With DNA
whole blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Inclusion Criteria:

  • Woman aged superior to 18 years old
  • Inform consent signed
  • Woman with breast cancer that have been diagnosed in clinic

Exclusion Criteria

  • No inform consent signed
  • Patient under guardianship, curatorship
  • Psychosocial disorder
Criteria

Inclusion Criteria:

  • Woman aged superior to 18 years old Inform consent signed Woman without breast cancer and family history of cancer

Exclusion Criteria:

  • No inform consent signed Patient under guardianship, curatorship Psychosocial disorder
Contacts and Locations
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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): NCT02886845


Contacts
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Contact: hongping song, PhD +86-29-84771663 Songhp@fmmu.edu.cn

Locations
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China, Shaanxi
The First Affiliated Hospital of Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710000
Contact: hongping song, Ph.D    +86-29-84771663    Songhp@fmmu.edu.cn   
Principal Investigator: hongping song         
Sponsors and Collaborators
Song Hongping
Investigators
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Principal Investigator: hongping song, PhD The First Affiliated Hospital of Fourth Military Medical University
More Information
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Responsible Party: Song Hongping, PhD, The First Affiliated Hospital of the Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT02886845    
Other Study ID Numbers: BRCA-Genetics-2016
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Song Hongping, The First Affiliated Hospital of the Fourth Military Medical University:
SNP,Breast Neoplasms