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Breast CancerNCT02889458

Hong Kong Breast Cancer Study

An observational study of Breast Cancer and Ductal Carcinoma In Situ, run by The University of Hong Kong at 21 sites in Hong Kong.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Ductal Carcinoma In Situ
What is being tested?
Not Provided
How many people
7,000 participants
Where
21 sitesHong Kong
Study dates
Sep 2016to Dec 2028
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Chinese female who usually reside in Hong Kong.

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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Hong Kong21 sites
  • Baptist Hospital

    Hong Kong

  • Caritas Medical Centre

    Hong Kong

  • Evangel Hospital

    Hong Kong

  • Grantham Hospital

    Hong Kong

  • HK Sanatorium and Hospital

    Hong Kong

  • Kwong Wah Hospital

    Hong Kong

  • North District Hospital

    Hong Kong

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong

  • Pok Oi Hospital

    Hong Kong

  • Prince of Wales Hospital

    Hong Kong

  • Princess Margaret Hospital

    Hong Kong

  • Queen Elizabeth Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

  • Ruttonjee Hospital

    Hong Kong

  • St. Paul's Hospital

    Hong Kong

  • St. Teresa's Hospital

    Hong Kong

  • Tseng Kwan O Hospital

    Hong Kong

  • Tuen Mun Hospital

    Hong Kong

  • Union Hospital

    Hong Kong

  • United Christian Hospital

    Hong Kong

  • Yan Chai Hospital

    Hong Kong

Other trials in Hong Kong

About this study

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

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.

Read more

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.

Being tested
Not Provided
Keywords
Chinese, Breast Cancer, Women
Medical subject headings
Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Not ProvidedOther

Study groups in NCT02889458
Study groupRoleWhat they receive
CaseInclusion 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.
Receives: Other: Not Provided
ControlInclusion 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.
Receives: Other: Not Provided

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionDec 2022
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
7,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02889458
Sponsor's protocol ID
BrCA.risk.001
Status last verified
May 2023
First submitted
31 Aug 2016
Last updated
23 May 2023
Results posted
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Ductal Carcinoma In Situ, run by The University of Hong Kong at 21 sites in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

probability of developing breast cancer (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.

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Hong Kong Breast Cancer Study (NCT02889458) | AzTrials