Breast CancerNCT01866631
Using National University Cancer Institute of Singapore (NCIS) Registry to Measure Time Trends in Quality of Care for Breast Cancer Patients in a National Cancer Centre
An observational study of Breast Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The investigators hypothesise that the research data will enable them to elucidate local clinical practices with regard to breast cancer care and enable them to extrpolate the data to improved local clinical care for their patients through self-regulation and audit. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 2,000 participants
- Where
- 1 siteSingapore
- Study dates
- Dec 2010to Dec 2013
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: To retropsectively review the NCIS registry of females diagnosed with breast cancer in years 2002 to 2008 with regards to clinical quality indicators as published by the European Sociaty of Breast Cancer Oncologists (Eur J Can 2010; 46:2344-2356). We will extract data from a pre-existing breast cancer registry which belongs to NCIS, looking at data which includes the following:(1) Completeness of clinical and imaging diagnostic work-up(2) Completeness of prognostic and predictive characterization(3) Multidisciplinary discussion(4) Appropriate surgical approach(5) Appropriate post-operative radiation(6) Avoidance of over-treatment(7) Appropraiet hormonal therapy(8) Appropriate chemotherapy and other medical therapy(9) Staging, counselling, follow-up and rehabilitative procedures
Who may be able to join
- Female
- 21 years old
Who cannot join
- No patient involved
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, Singapore, 119074
Sing Huang Tan, MBBS, 65 6779 5555, Sing_Huang_Tan@nuhs.edu.sg
Sing Huang Tan, MBBS
About this study
The investigators hypothesise that the research data will enable them to elucidate local clinical practices with regard to breast cancer care and enable them to extrpolate the data to improved local clinical care for their patients through self-regulation and audit.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of care at NCIS using indicators
Measured: 2 years
Secondary outcomes (1)
The trends and variations in quality of care indices over a period of years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startDec 2010
- Primary completionDec 2013 (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.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866631
- Sponsor's protocol ID
- BR08/30/10
- Status last verified
- Dec 2013
- First submitted
- 31 Oct 2012
- Last updated
- 10 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using National University Cancer Institute of Singapore (NCIS) Registry to Measure Time Trends in Quality of Care for Breast Cancer Patients in a National Cancer Centre
- ClinicalTrials.gov ID
- NCT01866631
- Acronym / sponsor ID
- BR08/30/10
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (estimated)
- First posted
- 31 May 2013 (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.
The investigators hypothesise that the research data will enable them to elucidate local clinical practices with regard to breast cancer care and enable them to extrpolate the data to improved local clinical care for their patients through self-regulation and audit.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To retropsectively review the NCIS registry of females diagnosed with breast cancer in years 2002 to 2008 with regards to clinical quality indicators as published by the European Sociaty of Breast Cancer Oncologists (Eur J Can 2010; 46:2344-2356). We will extract data from a pre-existing breast cancer registry which belongs to NCIS, looking at data which includes the following:(1) Completeness of clinical and imaging diagnostic work-up(2) Completeness of prognostic and predictive characterization(3) Multidisciplinary discussion(4) Appropriate surgical approach(5) Appropriate post-operative radiation(6) Avoidance of over-treatment(7) Appropraiet hormonal therapy(8) Appropriate chemotherapy and other medical therapy(9) Staging, counselling, follow-up and rehabilitative procedures
Key inclusion criteria (2 listed)
- Female
- 21 years old
Key exclusion criteria (1 listed)
- No patient involved
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
Quality of care at NCIS using indicators
Time frame: 2 years
1 secondary outcome
The trends and variations in quality of care indices over a period of years
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
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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.
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 National University Hospital, Singapore at 1 site in Singapore.
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 2 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 10 Dec 2013. 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 Singapore. 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 Sing Huang Tan, MBBS (65 6779 5555, Sing_Huang_Tan@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of care at NCIS using indicators (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 10 Dec 2013.