Hong Kong Breast Cancer Study

Active, not recruiting

• Conditions: Breast Cancer; Ductal Carcinoma In Situ
• Interventions: Other: Not Provided

• Registration Number: NCT02889458
• Lead Sponsor: The University of Hong Kong

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-08-31
• Study First Submitted QC: 2016-08-31
• Study Start: 2016-09
• Study First Posted: 2016-09-05
• Primary Completion: 2022-12
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-21
• Last Update Posted: 2023-05-23
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 7000

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case	Not Provided	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	Not Provided	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.

Primary Outcome Measures

Name	Time	Method
probability of developing breast cancer	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.

Trial Locations

Locations (21)

Pok Oi Hospital; 🇭🇰 Hong Kong, Hong Kong

Baptist Hospital; 🇭🇰 Hong Kong, Hong Kong

Union Hospital; 🇭🇰 Hong Kong, Hong Kong

St. Paul's Hospital; 🇭🇰 Hong Kong, Hong Kong

St. Teresa's Hospital; 🇭🇰 Hong Kong, Hong Kong

Ruttonjee Hospital; 🇭🇰 Hong Kong, Hong Kong

Queen Mary 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

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong

Princess Margaret Hospital; 🇭🇰 Hong Kong, Hong Kong

Queen Elizabeth Hospital; 🇭🇰 Hong Kong, Hong Kong

Tseng Kwan O Hospital; 🇭🇰 Hong Kong, Hong Kong

United Christian Hospital; 🇭🇰 Hong Kong, Hong Kong

Tuen Mun Hospital; 🇭🇰 Hong Kong, Hong Kong

Yan Chai Hospital; 🇭🇰 Hong Kong, Hong Kong