Breast CancerNCT05600257
The Effect of Digital Breast Tomosynthesis in Breast Cancer Long-term Survival: a Single Institution Study
An observational study of Breast Cancer, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial summary
To investigate whether digital breast tomosynthesis (DBT) benefits survival improvement. Read more about this study
- Who is it for?
- Ages 23 to 89 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- DBT and DM
- Type of treatment
- Medical device
- How many people
- 1,517 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2011to 31 Aug 2021
- 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 23 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Individuals were diagnosed with breast cancer according to the International Disease Classification Criteria from September 2011 to December 2015.
Who may be able to join
- individuals were diagnosed with breast cancer according to the International Disease Classification Criteria
Who cannot join
- no surgery or incomplete surgical pathology stage
- complete remission after neoadjuvant chemotherapy
- non-breast cancer death
- bilateral breast cancer
- male breast cancer
- no pre-surgery mammography image
Trial locations and contacts
1 site in 1 country.
About this study
To investigate whether digital breast tomosynthesis (DBT) benefits survival improvement.
Read the detailed description
To suggest DBT for specific populations, compare the overall survival rate of women with digital mammography (DM) to the DBT screening for women with particular characteristics.
- Conditions
- Breast Cancer
- Being tested
- DBT, DM
- Keywords
- 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.
DBTDevice
Also called Digital Breast Tomosynthesis
Image with digital breast tomosynthesis
DMDevice
Also called Digital Mammography
Image with digital mammography
| Study group | Role | What they receive |
|---|---|---|
| Screening cohort | Women received mammography screening Receives: Device: DBT; Device: DM | |
| Diagnostic cohort | Women received clinical breast examination Receives: Device: DBT; Device: DM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival rate
Compare the overall survival rate according to breast density type, cancer stage, mammography test type, and imaging modality.
Measured: Up to 111 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Sep 2011
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,517 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen-Pin Chou, Kaohsiung Veterans General Hospital.
- Investigators
- Chen-Pin Chou, MD, Principal investigator, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600257
- Sponsor's protocol ID
- KSVGH22-CT11-01
- Status last verified
- Nov 2022
- First submitted
- 26 Oct 2022
- Last updated
- 4 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available on reasonable request from the corresponding author. Some data are not publicly available due to their containing information that could compromise the privacy of research participants.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Digital Breast Tomosynthesis in Breast Cancer Long-term Survival: a Single Institution Study
- ClinicalTrials.gov ID
- NCT05600257
- Acronym / sponsor ID
- KSVGH22-CT11-01
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,517 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 1 Sep 2011 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 31 Oct 2022 (actual)
- 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 investigate whether digital breast tomosynthesis (DBT) benefits survival improvement.
Detailed description
To suggest DBT for specific populations, compare the overall survival rate of women with digital mammography (DM) to the DBT screening for women with particular characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening cohort | – | Device: DBT, Device: DMWomen received mammography screening |
| Diagnostic cohort | – | Device: DBT, Device: DMWomen received clinical breast examination |
Who may qualify
- Ages
- 23 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals were diagnosed with breast cancer according to the International Disease Classification Criteria from September 2011 to December 2015.
Key inclusion criteria (1 listed)
- individuals were diagnosed with breast cancer according to the International Disease Classification Criteria
Key exclusion criteria (6 listed)
- no surgery or incomplete surgical pathology stage
- complete remission after neoadjuvant chemotherapy
- non-breast cancer death
- bilateral breast cancer
- male breast cancer
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 |
|---|---|---|
| DBTAlso: Digital Breast TomosynthesisImage with digital breast tomosynthesis | Device | Diagnostic cohort, Screening cohort |
| DMAlso: Digital MammographyImage with digital mammography | Device | Diagnostic cohort, Screening cohort |
Primary outcome
Overall survival rate
Time frame: Up to 111 months
Compare the overall survival rate according to breast density type, cancer stage, mammography test type, and imaging modality.
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 4 Nov 2022.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available on reasonable request from the corresponding author. Some data are not publicly available due to their containing information that could compromise the privacy of research participants.
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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.
Chen-Pin Chou, MD principal investigator
Kaohsiung Veterans General Hospital.
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 Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
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 6 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 4 Nov 2022. 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 Taiwan. 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?
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?
Overall survival rate (time frame: Up to 111 months). 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 4 Nov 2022.