Case Control StudyNCT02771665
Mammographic Density and the Risk of Tumor Recurrence in Asian Women: a Case-control Study
An observational study of Case Control Study, run by National Taiwan University Hospital.
Trial summary
To evaluate the influence of mammographic breast density at diagnosis on the risk of cancer recurrence and survival outcome in patients with invasive breast cancer after surgery Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Case Control Study
- What is being tested?
- Mammographic breast density at diagnosis
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Mar 2015
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women diagnosed with invasive breast cancer who had undergone surgery between 2004 and 2009
Who may be able to join
- Women diagnosed with invasive breast cancer between 2004 and 2009 who had undergone surgery and had the mammographic breast density ascertained before, or at, diagnosis.
Who cannot join
- Women diagnosed with invasive breast cancer between 2004 and 2009 who had not undergone surgery or who had no mammographic breast density ascertained before, or at, diagnosis.
About this study
To evaluate the influence of mammographic breast density at diagnosis on the risk of cancer recurrence and survival outcome in patients with invasive breast cancer after surgery
- Conditions
- Case Control Study
- Being tested
- Mammographic breast density at diagnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mammographic breast density at diagnosisOther
Mammographic breast density at diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer women with known recurrences | Breast cancer women with known recurrences (locoregional recurrence and distant metastasis) Receives: Other: Mammographic breast density at diagnosis | |
| Breast cancer women without recurrences | Breast cancer women without recurrences Receives: Other: Mammographic breast density at diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hazard ratios for recurrence
Measured: 2004 to 2009
Secondary outcomes (1)
Hazard ratios for death
Measured: 2004 to 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Case Control StudyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jenny Ling-Yu Chen, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771665
- Sponsor's protocol ID
- 201401068RIND
- Status last verified
- May 2016
- First submitted
- 11 May 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Huang YS, Chen JL, Huang CS, Kuo SH, Jaw FS, Tseng YH, Ko WC, Chang YC. High mammographic breast density predicts locoregional recurrence after modified radical mastectomy for invasive breast cancer: a case-control study. Breast Cancer Res. 2016 Dec 1;18(1):120. doi: 10.1186/s13058-016-0784-3.
PubMed 27906044
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mammographic Density and the Risk of Tumor Recurrence in Asian Women: a Case-control Study
- ClinicalTrials.gov ID
- NCT02771665
- Acronym / sponsor ID
- 201401068RIND
- Conditions
- Case Control Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 May 2016 (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.
To evaluate the influence of mammographic breast density at diagnosis on the risk of cancer recurrence and survival outcome in patients with invasive breast cancer after surgery
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer women with known recurrences | – | Other: Mammographic breast density at diagnosisBreast cancer women with known recurrences (locoregional recurrence and distant metastasis) |
| Breast cancer women without recurrences | – | Other: Mammographic breast density at diagnosisBreast cancer women without recurrences |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women diagnosed with invasive breast cancer who had undergone surgery between 2004 and 2009
Key inclusion criteria (1 listed)
- Women diagnosed with invasive breast cancer between 2004 and 2009 who had undergone surgery and had the mammographic breast density ascertained before, or at, diagnosis.
Key exclusion criteria (1 listed)
- Women diagnosed with invasive breast cancer between 2004 and 2009 who had not undergone surgery or who had no mammographic breast density ascertained before, or at, diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mammographic breast density at diagnosisMammographic breast density at diagnosis | Other | Breast cancer women with known recurrences, Breast cancer women without recurrences |
Primary outcome
Hazard ratios for recurrence
Time frame: 2004 to 2009
1 secondary outcome
Hazard ratios for death
Time frame: 2004 to 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Derived from this study: PubMed 27906044Huang YS, Chen JL, Huang CS, Kuo SH, Jaw FS, Tseng YH, Ko WC, Chang YC. High mammographic breast density predicts locoregional recurrence after modified radical mastectomy for invasive breast cancer: a case-control study. Breast Cancer Res. 2016 Dec 1;18(1):120. doi: 10.1186/s13058-016-0784-3.
- Individual participant dataSharing planned: No
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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.
Jenny Ling-Yu Chen, MD principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Case Control Study, run by National Taiwan University Hospital.
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 1 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: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hazard ratios for recurrence (time frame: 2004 to 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02771665, which also lists 1 linked publication.
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 13 May 2016.