Hong Kong Breast Cancer Study

May 21, 2023 updated by: Professor Gabriel Matthew Leung, The University of Hong Kong

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.

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

7000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital
      • Hong Kong, Hong Kong
        • Princess Margaret Hospital
      • Hong Kong, Hong Kong
        • Queen Elizabeth Hospital
      • Hong Kong, Hong Kong
        • Kwong Wah Hospital
      • Hong Kong, Hong Kong
        • Grantham Hospital
      • Hong Kong, Hong Kong
        • United Christian Hospital
      • Hong Kong, Hong Kong
        • Pamela Youde Nethersole Eastern Hospital
      • Hong Kong, Hong Kong
        • Yan Chai Hospital
      • Hong Kong, Hong Kong
        • Caritas Medical Centre
      • Hong Kong, Hong Kong
        • North District Hospital
      • Hong Kong, Hong Kong
        • Pok Oi Hospital
      • Hong Kong, Hong Kong
        • Ruttonjee Hospital
      • Hong Kong, Hong Kong
        • Baptist Hospital
      • Hong Kong, Hong Kong
        • Evangel Hospital
      • Hong Kong, Hong Kong
        • HK Sanatorium and 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
        • Union Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Chinese female who usually reside in Hong Kong.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other: Not Provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Food and Health Bureau, Hong Kong Government

Investigators

  • Principal Investigator: Gabriel M Leung, MD, Li Ka Shing Faculty of Medicine, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

December 1, 2022

Study Completion (Anticipated)

December 1, 2028

Study Registration Dates

First Submitted

August 31, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 5, 2016

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 21, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BrCA.risk.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information identifier: BrCA.risk.001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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