Recall RateDBTNCT01248546
Tomosynthesis in the Oslo Breast Cancer Screening Program
An observational study of Recall Rate and Cancer Detection Rate, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The Digital Breast Tomosynthesis (DBT) in the Oslo Mammography Screening Program will include women aged 50 to 69 years invited to the population-based mammography-screening program. All women attending the screening unit will be asked if they want to attend the trial. Read more about this study
- Who is it for?
- Ages 50 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recall Rate, Cancer Detection Rate, False Positive Rate
- What is being tested?
- Digital breast tomosynthesis
- Type of treatment
- Surgery or procedure
- How many people
- 25,000 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2010to Sep 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 50 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women aged 50 to 69 years attending the national breast cancer screening program who sign an informed consent regarding participation in the trial
Who may be able to join
- Women 50 to 69 years who have signed the informed consent
Who cannot join
- Women with pacemaker, implants, and severely disabled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Digital Breast Tomosynthesis in the Oslo Mammography Screening Program
The Digital Breast Tomosynthesis (DBT) in the Oslo Mammography Screening Program will include women aged 50 to 69 years invited to the population-based mammography-screening program. All women attending the screening unit will be asked if they want to attend the trial. If so, they will be informed about the project, the technique, and the additional compression and radiation dose. All mammographic examinations of women attending the trial will be independently interpreted by four radiologists. Since the trial is part of the official Norwegian Breast Cancer Screening Program (NBCSP), the interpretations will be carried out on-line into the national screening database of the NBCSP. The study will include independent reading of conventional digital (2D) mammograms, 2D plus computer-aided detection (CAD), 2D plus DBT, and synthetic 2D plus DBT. There will be a common consensus meeting for all examinations having a positive score. Recalls and diagnostic work-up will be according to daily practice at the Oslo University Hospital Ullevaal and the guidelines of the NBCSP.
Outcome measures will use performance indicators for organized screening programs, including recall rate, false positive scores, cancer detection rate, positive predictive values, and cancer characteristics for the individual readers of the trial.
- Being tested
- Digital breast tomosynthesis
- Keywords
- Breast cancer, Computer-aided detection, Mammography screening, Digital breast tomosynthesis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital breast tomosynthesisProcedure or surgery
The participants included in the trial will have an additional radiation exposure for breast tomosynthesis
| Study group | Role | What they receive |
|---|---|---|
| Digital mammography | Not described Receives: Procedure: Digital breast tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening performance indicators
Measured: From Nov. 22, 2010 to Dec. 31, 2012
Secondary outcomes (1)
Interval cancer rate
Measured: From Nov. 23, 2010 to Dec. 31, 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2012
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Recall RateStudies of the same condition, open and under way.
- More trials run by Oslo 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Institute of Public Health, Hologic, Inc.
- Responsible party
- Principal investigator, Per Skaane, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248546
- Sponsor's protocol ID
- 2010/144 (REK)
- Acronym
- DBT
- Status last verified
- Feb 2013
- First submitted
- 24 Nov 2010
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Skaane P, Sebuodegard S, Bandos AI, Gur D, Osteras BH, Gullien R, Hofvind S. Performance of breast cancer screening using digital breast tomosynthesis: results from the prospective population-based Oslo Tomosynthesis Screening Trial. Breast Cancer Res Treat. 2018 Jun;169(3):489-496. doi: 10.1007/s10549-018-4705-2. Epub 2018 Feb 10.
PubMed 29429017Skaane P, Bandos AI, Gullien R, Eben EB, Ekseth U, Haakenaasen U, Izadi M, Jebsen IN, Jahr G, Krager M, Niklason LT, Hofvind S, Gur D. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology. 2013 Apr;267(1):47-56. doi: 10.1148/radiol.12121373. Epub 2013 Jan 7.
PubMed 23297332
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Breast Tomosynthesis in the Oslo Mammography Screening Program
- ClinicalTrials.gov ID
- NCT01248546
- Acronym / sponsor ID
- DBT / 2010/144 (REK)
- Keywords
- Breast cancer, Computer-aided detection, Mammography screening, Digital breast tomosynthesis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Institute of Public Health, Hologic, Inc.
- Study start
- Nov 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Sep 2015 (estimated)
- First posted
- 25 Nov 2010 (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 Digital Breast Tomosynthesis (DBT) in the Oslo Mammography Screening Program will include women aged 50 to 69 years invited to the population-based mammography-screening program. All women attending the screening unit will be asked if they want to attend the trial. If so, they will be informed about the project, the technique, and the additional compression and radiation dose. All mammographic examinations of women attending the trial will be independently interpreted by four radiologists. Since the trial is part of the official Norwegian Breast Cancer Screening Program (NBCSP), the interpretations will be carried out on-line into the national screening database of the NBCSP. The study will include independent reading of conventional digital (2D) mammograms, 2D plus computer-aided detection (CAD), 2D plus DBT, and synthetic 2D plus DBT. There will be a common consensus meeting for all examinations having a positive score. Recalls and diagnostic work-up will be according to daily practice at the Oslo University Hospital Ullevaal and the guidelines of the NBCSP.
Outcome measures will use performance indicators for organized screening programs, including recall rate, false positive scores, cancer detection rate, positive predictive values, and cancer characteristics for the individual readers of the trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital mammography | – | Procedure: Digital breast tomosynthesis |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women aged 50 to 69 years attending the national breast cancer screening program who sign an informed consent regarding participation in the trial
Key inclusion criteria (1 listed)
- Women 50 to 69 years who have signed the informed consent
Key exclusion criteria (1 listed)
- Women with pacemaker, implants, and severely disabled
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 |
|---|---|---|
| Digital breast tomosynthesisThe participants included in the trial will have an additional radiation exposure for breast tomosynthesis | Procedure or surgery | Digital mammography |
Primary outcome
Screening performance indicators
Time frame: From Nov. 22, 2010 to Dec. 31, 2012
1 secondary outcome
Interval cancer rate
Time frame: From Nov. 23, 2010 to Dec. 31, 2014
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
- Derived from this study: PubMed 29429017Skaane P, Sebuodegard S, Bandos AI, Gur D, Osteras BH, Gullien R, Hofvind S. Performance of breast cancer screening using digital breast tomosynthesis: results from the prospective population-based Oslo Tomosynthesis Screening Trial. Breast Cancer Res Treat. 2018 Jun;169(3):489-496. doi: 10.1007/s10549-018-4705-2. Epub 2018 Feb 10.
- Derived from this study: PubMed 23297332Skaane P, Bandos AI, Gullien R, Eben EB, Ekseth U, Haakenaasen U, Izadi M, Jebsen IN, Jahr G, Krager M, Niklason LT, Hofvind S, Gur D. Comparison of digital mammography alone and digital mammography plus tomosynthesis in a population-based screening program. Radiology. 2013 Apr;267(1):47-56. doi: 10.1148/radiol.12121373. Epub 2013 Jan 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Recall Rate and Cancer Detection Rate, run by Oslo University Hospital at 1 site in Norway.
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: status not confirmed, as of the sponsor's last update on 5 Feb 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 Norway. 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?
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?
Screening performance indicators (time frame: From Nov. 22, 2010 to Dec. 31, 2012). 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 NCT01248546, which also lists 2 linked publications.
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 5 Feb 2013.