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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02889458
Other study ID # BrCA.risk.001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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