Genotyping 2 SNPs in Chinese Breast Cancers

January 13, 2022 updated by: Song Hongping

Study of Two Single Nucleotide Polymorphisms in Chinese Breast Cancers

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 .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Recruiting
        • The First Affiliated Hospital of Fourth Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
June of 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Song Hongping

Investigators

  • Principal Investigator: hongping song, PhD, The First Affiliated Hospital of Fourth Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2023

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

August 29, 2016

First Posted (ESTIMATE)

September 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BRCA-Genetics-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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