Breast CancerNCT02889458
Hong Kong Breast Cancer Study
An observational study of Breast Cancer and Ductal Carcinoma In Situ, run by The University of Hong Kong at 21 sites in Hong Kong.
Trial summary
Introduction: With population ageing and increasing Westernization breast cancer continues to be important health conditions among women in Hong Kong. Greater collaborative research efforts are needed to examine the questions about population screening for breast cancer, the aetiology of such lesions and outcomes of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Ductal Carcinoma In Situ
- What is being tested?
- Not Provided
- How many people
- 7,000 participants
- Where
- 21 sitesHong Kong
- Study dates
- Sep 2016to Dec 2028
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Chinese female who usually reside in Hong Kong.
Case Inclusion Criteria:
- Female
- aged 18 or above
- Chinese
- Usually residing in Hong Kong (Definition: Having stayed in HK for at least three months during the six months before the reference time-point)
- Able to speak Cantonese
- Newly diagnosed with breast cancer or DCIS in 24 weeks
Case Exclusion Criteria:
- Undergoing treatment for any non-breast cancer
Control Inclusion Criteria
- Female
- aged 18 or above
- Chinese
- Usually residing in Hong Kong
- Able to speak Cantonese
Control Exclusion Criteria
- History of any cancer
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Hong Kong21 sites
Baptist Hospital
Hong Kong
Caritas Medical Centre
Hong Kong
Evangel Hospital
Hong Kong
Grantham Hospital
Hong Kong
HK Sanatorium and Hospital
Hong Kong
Kwong Wah Hospital
Hong Kong
North District Hospital
Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong
Pok Oi Hospital
Hong Kong
Prince of Wales Hospital
Hong Kong
Princess Margaret Hospital
Hong Kong
Queen Elizabeth Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Ruttonjee Hospital
Hong Kong
St. Paul's Hospital
Hong Kong
St. Teresa's Hospital
Hong Kong
Tseng Kwan O Hospital
Hong Kong
Tuen Mun Hospital
Hong Kong
Union Hospital
Hong Kong
United Christian Hospital
Hong Kong
Yan Chai Hospital
Hong Kong
About this study
Official title: Preventing Breast Cancer in Hong Kong Chinese Women Through Personalized Risk Stratification and Characterization: an Epidemiologic Modeling Study and the Development of a Biorepository of Cases and Controls
Introduction: With population ageing and increasing Westernization breast cancer continues to be important health conditions among women in Hong Kong. Greater collaborative research efforts are needed to examine the questions about population screening for breast cancer, the aetiology of such lesions and outcomes of breast cancer during survivorship period. There is a lack of locally-relevant models for assessing breast cancer risk. Contribution of novel genetic factors to breast cancer, identification of the key and functional alleles in gene regions associated with risk of breast cancer as well as gene-environment interaction, requires further investigation in Chinese population. Prognostic research studies in the West may not be readily applicable to the Chinese population.
Objectives: We aim to investigate the aetiology and outcomes of breast cancer in local Chinese by using case-control and cohort study design in the health care setting in Hong Kong. We aim to examine potential risk factors/biomarkers (both traditional and novel), and to build infrastructure and biobank for breast cancer surveillance. We will follow up cases prospectively as a survivor cohort.
Read more
Methods: A hospital-based case-control study and a prospective survivor cohort study will be conducted. Consecutive incident breast cancer and DCIS cases (n=3,501) within a 36-month period in Hong Kong were recruited from public hospitals, private hospitals and private practices; and controls were selected by frequency-matching on factors such as age and hospital/clinic setting, whenever possible. Cases will be prospectively followed up over a 10-year period, and data collection will occur at baseline (within 24 weeks of diagnosis), 3, 5 and 10 years following baseline assessment. Biologic samples (including both blood, and tumour and normal breast tissue samples from the cases, and blood samples from the controls) will be collected for later genetic and molecular study including WGS, GWAS, gene-environment interaction and molecular functional studies. Depending on availability of pathology samples and resources, additional studies such as tissue microarray block production will be considered and performed in future. Data will be analysed by traditional regression, EWAS and genetic association methods, whenever relevant.
Public Health Implications: The repository of clinical, radiological and biological materials assembled through this case-control study will serve as a common, publicly accessible platform for subsequent functional analysis and scientific interrogation. The case-control findings would offer an improved understanding to the state of the science on aetiology of breast cancer in Chinese women. In the genomics analysis, potential refined classification of breast tumours may enhance our understanding, detection and follow-up of such lesions, as well as enable us to have more informed targeted and personalized treatment selection for our women population. The cohort study findings are important for developing an effective strategy for the improvement of overall survival and quality of life for the cancer survivors in Chinese population.
- Conditions
- Breast Cancer, Ductal Carcinoma In Situ
- Being tested
- Not Provided
- Keywords
- Chinese, Breast Cancer, Women
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not ProvidedOther
| Study group | Role | What they receive |
|---|---|---|
| Case | Inclusion Criteria
* Female
* aged 18 or above
* Chinese
* Usually residing in Hong Kong (Definition: Having stayed in HK for at least three months during the six months before the reference time-point)
* Able to speak Cantonese
* Newly diagnosed with breast cancer or DCIS in 24 weeks
Exclusion Criteria
- Undergoing treatment for any non-breast cancer
Subjects will complete a structured interview with a questionnaire with research assistants' aid. Specimen of blood, normal breast tissue and tumour tissue will be collected. Receives: Other: Not Provided | |
| Control | Inclusion Criteria
* Female
* aged 18 or above
* Chinese
* Usually residing in Hong Kong
* Able to speak Cantonese
Exclusion Criteria
- History of any cancer
Subjects will complete a structured interview with a questionnaire with research assistants' aid. Specimen of blood will be collected. Receives: Other: Not Provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
probability of developing breast cancer
We will estimate individualized breast cancer probabilities based on information on relative risks and the baseline hazard rate in Hong Kong Chinese women population. Risk factors will include age, age at menarche, age at first birth, family history of breast cancer, prior breast benign disease diagnosis, menopausal status, dietary pattern. Structured interviews will be provided by our trained interviewers to collect these data by using our survey questionnaire.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2022
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- 7,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong
- Responsible party
- Principal investigator, Professor Gabriel Matthew Leung, The University of Hong Kong
- Investigators
- Gabriel M Leung, MD, Principal investigator, Li Ka Shing Faculty of Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889458
- Sponsor's protocol ID
- BrCA.risk.001
- Status last verified
- May 2023
- First submitted
- 31 Aug 2016
- Last updated
- 23 May 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Breast Cancer in Hong Kong Chinese Women Through Personalized Risk Stratification and Characterization: an Epidemiologic Modeling Study and the Development of a Biorepository of Cases and Controls
- ClinicalTrials.gov ID
- NCT02889458
- Acronym / sponsor ID
- BrCA.risk.001
- Conditions
- Breast Cancer, Ductal Carcinoma In Situ
- Keywords
- Chinese, Breast Cancer, Women
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Food and Health Bureau, Hong Kong
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 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.
Introduction: With population ageing and increasing Westernization breast cancer continues to be important health conditions among women in Hong Kong. Greater collaborative research efforts are needed to examine the questions about population screening for breast cancer, the aetiology of such lesions and outcomes of breast cancer during survivorship period. There is a lack of locally-relevant models for assessing breast cancer risk. Contribution of novel genetic factors to breast cancer, identification of the key and functional alleles in gene regions associated with risk of breast cancer as well as gene-environment interaction, requires further investigation in Chinese population. Prognostic research studies in the West may not be readily applicable to the Chinese population.
Objectives: We aim to investigate the aetiology and outcomes of breast cancer in local Chinese by using case-control and cohort study design in the health care setting in Hong Kong. We aim to examine potential risk factors/biomarkers (both traditional and novel), and to build infrastructure and biobank for breast cancer surveillance. We will follow up cases prospectively as a survivor cohort.
Methods: A hospital-based case-control study and a prospective survivor cohort study will be conducted. Consecutive incident breast cancer and DCIS cases (n=3,501) within a 36-month period in Hong Kong were recruited from public hospitals, private hospitals and private practices; and controls were selected by frequency-matching on factors such as age and hospital/clinic setting, whenever possible. Cases will be prospectively followed up over a 10-year period, and data collection will occur at baseline (within 24 weeks of diagnosis), 3, 5 and 10 years following baseline assessment. Biologic samples (including both blood, and tumour and normal breast tissue samples from the cases, and blood samples from the controls) will be collected for later genetic and molecular study including WGS, GWAS, gene-environment interaction and molecular functional studies. Depending on availability of pathology samples and resources, additional studies such as tissue microarray block production will be considered and performed in future. Data will be analysed by traditional regression, EWAS and genetic association methods, whenever relevant.
Public Health Implications: The repository of clinical, radiological and biological materials assembled through this case-control study will serve as a common, publicly accessible platform for subsequent functional analysis and scientific interrogation. The case-control findings would offer an improved understanding to the state of the science on aetiology of breast cancer in Chinese women. In the genomics analysis, potential refined classification of breast tumours may enhance our understanding, detection and follow-up of such lesions, as well as enable us to have more informed targeted and personalized treatment selection for our women population. The cohort study findings are important for developing an effective strategy for the improvement of overall survival and quality of life for the cancer survivors in Chinese population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: Not ProvidedInclusion Criteria * Female * aged 18 or above * Chinese * Usually residing in Hong Kong (Definition: Having stayed in HK for at least three months during the six months before the reference time-point) * Able to speak Cantonese * Newly diagnosed with breast cancer or DCIS in 24 weeks Exclusion Criteria - Undergoing treatment for any non-breast cancer Subjects will complete a structured interview with a questionnaire with research assistants' aid. Specimen of blood, normal breast tissue and tumour tissue will be collected. |
| Control | – | Other: Not ProvidedInclusion Criteria * Female * aged 18 or above * Chinese * Usually residing in Hong Kong * Able to speak Cantonese Exclusion Criteria - History of any cancer Subjects will complete a structured interview with a questionnaire with research assistants' aid. Specimen of blood will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese female who usually reside in Hong Kong.
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 |
|---|---|---|
| Not Provided | Other | Case, Control |
Primary outcome
probability of developing breast cancer
Time frame: 2 years
We will estimate individualized breast cancer probabilities based on information on relative risks and the baseline hazard rate in Hong Kong Chinese women population. Risk factors will include age, age at menarche, age at first birth, family history of breast cancer, prior breast benign disease diagnosis, menopausal status, dietary pattern. Structured interviews will be provided by our trained interviewers to collect these data by using our survey questionnaire.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Individual participant dataSharing planned: No
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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.
Gabriel M Leung, MD principal investigator
Li Ka Shing Faculty of Medicine, The University of Hong Kong
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Ductal Carcinoma In Situ, run by The University of Hong Kong at 21 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
probability of developing breast cancer (time frame: 2 years). 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 23 May 2023.