Breast CancerNCT00509509
High Risk Breast Cancer Screening Program
An observational study of Breast Cancer, run by Organisation for Oncology and Translational Research at 1 site in Hong Kong.
Trial summary
Objectives: To screen population with high risk for breast cancer To promote the concept and importance of surveillance mammography To find out the incidence of breast cancer in population who are in high risk for breast cancer To collect blood samples for molecular analysis Read more about this study
- Who is it for?
- Ages 41 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- Not given
- Where
- 1 siteHong Kong
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
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 41 years and older
- Women only
- Adult, Older adult
Study population: Women aged over 40 with high risk of breast cancer
Who may be able to join
- Female
- > 40 years of age
- Women who have first-degree relative suffered from breast cancer
- Women who have first-degree relative suffered from ovarian cancer
- Family history of male breast cancer
- Family history of breast cancer (not necessarily first degree relatives) diagnosed before age of 40
Show all 9Show fewer
- Family history of breast cancer (not necessarily first degree relatives) affecting 2 or more family members
- Personal history of ovarian cancer
- Personal history of premalignant conditions of breast and ovary
Who cannot join
- Women with mammogram within one year
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
UNIMED Medical Institute
Wan Chai
Louis WC Chow, (852)2861 0286, lwcchow@unimed.hk
About this study
Objectives:
- To screen population with high risk for breast cancer
- To promote the concept and importance of surveillance mammography
- To find out the incidence of breast cancer in population who are in high risk for breast cancer
- To collect blood samples for molecular analysis
- Conditions
- Breast Cancer
- Keywords
- Hereditary Breast Cancer (BRCA1, BRCA2)
- Medical subject headings
- Breast Neoplasms, Breast Cancer, Familial, Fanconi Anemia, Complementation Group D1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Organisation for Oncology and Translational Research
- Sponsor type
- University, hospital or other
- Investigators
- Louis WC Chow, Principal investigator, UNIMED Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509509
- Sponsor's protocol ID
- OOTR-SBR001
- Status last verified
- May 2012
- First submitted
- 29 Jul 2007
- Last updated
- 24 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Risk Breast Cancer Screening Program
- ClinicalTrials.gov ID
- NCT00509509
- Acronym / sponsor ID
- OOTR-SBR001
- Conditions
- Breast Cancer
- Keywords
- Hereditary Breast Cancer (BRCA1, BRCA2)
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- Organisation for Oncology and Translational ResearchUniversity, hospital or other
- First posted
- 31 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
- To screen population with high risk for breast cancer
- To promote the concept and importance of surveillance mammography
- To find out the incidence of breast cancer in population who are in high risk for breast cancer
- To collect blood samples for molecular analysis
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 41 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women aged over 40 with high risk of breast cancer
Key inclusion criteria (9 listed)
- Female
- > 40 years of age
- Women who have first-degree relative suffered from breast cancer
- Women who have first-degree relative suffered from ovarian cancer
- Family history of male breast cancer
Key exclusion criteria (1 listed)
- Women with mammogram within one year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis WC Chow principal investigator
UNIMED Medical Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Organisation for Oncology and Translational Research at 1 site 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?
The sponsor lists 9 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 24 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louis WC Chow ((852)2861 0286, lwcchow@unimed.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 24 May 2012.