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| Name | Class |
|---|---|
| Norwegian Institute of Public Health | OTHER_GOV |
| Hologic, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital mammography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital breast tomosynthesis | Procedure | The participants included in the trial will have an additional radiation exposure for breast tomosynthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Screening performance indicators | From Nov. 22, 2010 to Dec. 31, 2012 |
| Measure | Description | Time Frame |
|---|---|---|
| Interval cancer rate | From Nov. 23, 2010 to Dec. 31, 2014 |
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Inclusion Criteria:
Exclusion Criteria:
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Women aged 50 to 69 years attending the national breast cancer screening program who sign an informed consent regarding participation in the trial
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital, Ulleval | Oslo | Oslo | 0407 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29429017 | Derived | 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. | |
| 23297332 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Skaane 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. |
| D017437 |
| Skin and Connective Tissue Diseases |