rs185670819 and rs183489969NCT02886845
Genotyping 2 SNPs in Chinese Breast Cancers
An observational study of rs185670819 and rs183489969, run by Song Hongping at 1 site in China.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- rs185670819 and rs183489969
- What is being tested?
- rs183489969,rs185670819
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Woman aged superior to 18 years old Inform consent signed Woman without breast cancer and family history of cancer
Who cannot join
- No inform consent signed Patient under guardianship, curatorship Psychosocial disorder
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Fourth Military Medical University
Xi'an, Shaanxi, 710000
hongping song, Ph.D, +86-29-84771663, Songhp@fmmu.edu.cn
hongping song
About this study
Official title: 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 .
Read the 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
- Conditions
- rs185670819 and rs183489969
- Being tested
- rs183489969,rs185670819
- Keywords
- SNP,Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rs183489969,rs185670819Genetic
compare the frequency of two germline mutations in breast cancers and controls
| Study group | Role | What they receive |
|---|---|---|
| Chinese Breast Cancers | Woman with breast cancer that have been diagnosed in clinic Receives: Genetic: rs183489969,rs185670819 | |
| healthy controls | Woman without breast cancer Receives: Genetic: rs183489969,rs185670819 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotyping of 2 SNPs ( rs185670819 and rs183489969) in Chinese breast cancer patients and age-matched healthy control women .
Measured: January of 2019
Secondary outcomes (1)
Both of the 2 SNPs' minor allele frequency or affected ratio shows statistically significant differences between case and control groups
Measured: June of 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for rs185670819 and rs183489969Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Song Hongping
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Song Hongping, The First Affiliated Hospital of the Fourth Military Medical University
- Investigators
- hongping song, PhD, Principal investigator, The First Affiliated Hospital of Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886845
- Sponsor's protocol ID
- BRCA-Genetics-2016
- Status last verified
- Jan 2022
- First submitted
- 29 Aug 2016
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Two Single Nucleotide Polymorphisms in Chinese Breast Cancers
- ClinicalTrials.gov ID
- NCT02886845
- Acronym / sponsor ID
- BRCA-Genetics-2016
- Conditions
- rs185670819 and rs183489969
- Keywords
- SNP,Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Song HongpingUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 1 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese Breast Cancers | – | Genetic: rs183489969,rs185670819Woman with breast cancer that have been diagnosed in clinic |
| healthy controls | – | Genetic: rs183489969,rs185670819Woman without breast cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Woman aged superior to 18 years old Inform consent signed Woman without breast cancer and family history of cancer
Key exclusion criteria (1 listed)
- No inform consent signed Patient under guardianship, curatorship Psychosocial disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rs183489969,rs185670819compare the frequency of two germline mutations in breast cancers and controls | Genetic | Chinese Breast Cancers, healthy controls |
Primary outcome
Genotyping of 2 SNPs ( rs185670819 and rs183489969) in Chinese breast cancer patients and age-matched healthy control women .
Time frame: January of 2019
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hongping song, PhD principal investigator
The First Affiliated Hospital of Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of rs185670819 and rs183489969, run by Song Hongping at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hongping song, PhD (+86-29-84771663, Songhp@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genotyping of 2 SNPs ( rs185670819 and rs183489969) in Chinese breast cancer patients and age-matched healthy control women . (time frame: January of 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.