Hong Kong Breast Cancer Study

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02889458
• Other study ID #: BrCA.risk.001
• Status: Active, not recruiting
• Start date: September 2016
• Est. completion date: December 2028

Study information

• Verified date: May 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7000
• Est. completion date: December 2028
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma In Situ

Intervention

Other:
• Not Provided

Locations

Country	Name	City	State
Hong Kong	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

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Food and Health Bureau, Hong Kong Government

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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