Hong Kong Breast Cancer Study
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
1 other identifier
observational
7,000
1 country
21
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2016
Longer than P75 for all trials
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedFirst Posted
Study publicly available on registry
September 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
ExpectedMay 23, 2023
May 1, 2023
6.3 years
August 31, 2016
May 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 years
Study Arms (2)
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.
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.
Interventions
Eligibility Criteria
Chinese female who usually reside in Hong Kong.
You may qualify if:
- 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
You may not qualify if:
- Undergoing treatment for any non-breast cancer
- Female
- aged 18 or above
- Chinese
- Usually residing in Hong Kong
- Able to speak Cantonese
- \- History of any cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Hong Konglead
- Food and Health Bureau, Hong Kongcollaborator
Study Sites (21)
Baptist Hospital
Hong Kong, Hong Kong
Caritas Medical Centre
Hong Kong, Hong Kong
Evangel Hospital
Hong Kong, Hong Kong
Grantham Hospital
Hong Kong, Hong Kong
HK Sanatorium and Hospital
Hong Kong, Hong Kong
Kwong Wah Hospital
Hong Kong, Hong Kong
North District Hospital
Hong Kong, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
Pok Oi Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Hong Kong, Hong Kong
Princess Margaret Hospital
Hong Kong, Hong Kong
Queen Elizabeth Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Ruttonjee Hospital
Hong Kong, Hong Kong
St. Paul's Hospital
Hong Kong, Hong Kong
St. Teresa's Hospital
Hong Kong, Hong Kong
Tseng Kwan O Hospital
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Union Hospital
Hong Kong, Hong Kong
United Christian Hospital
Hong Kong, Hong Kong
Yan Chai Hospital
Hong Kong, Hong Kong
Biospecimen
Blood, normal breast tissue, and tumour tissue.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel M Leung, MD
Li Ka Shing Faculty of Medicine, The University of Hong Kong
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dean, Li Ka Shing Faculty of Medicine
Study Record Dates
First Submitted
August 31, 2016
First Posted
September 5, 2016
Study Start
September 1, 2016
Primary Completion
December 1, 2022
Study Completion (Estimated)
December 1, 2028
Last Updated
May 23, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share