Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
7000 participants
OBSERVATIONAL
2016-09-30
2028-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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.
Not Provided
Interventions
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Not Provided
Eligibility Criteria
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Inclusion Criteria
* 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
* Female
* aged 18 or above
* Chinese
* Usually residing in Hong Kong
* Able to speak Cantonese
Exclusion Criteria
\- History of any cancer
18 Years
FEMALE
No
Sponsors
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Food and Health Bureau, Hong Kong
OTHER_GOV
The University of Hong Kong
OTHER
Responsible Party
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Professor Gabriel Matthew Leung
Dean, Li Ka Shing Faculty of Medicine
Principal Investigators
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Gabriel M Leung, MD
Role: PRINCIPAL_INVESTIGATOR
Li Ka Shing Faculty of Medicine, The University of Hong Kong
Locations
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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
Countries
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Study Documents
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Document Type: Study Protocol
View DocumentOther Identifiers
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BrCA.risk.001
Identifier Type: -
Identifier Source: org_study_id
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