Tomosynthesis in the Oslo Breast Cancer Screening Program (DBT)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

The Norwegian Cancer Registry

Hologic, Inc.

Information provided by (Responsible Party):

Per Skaane, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT01248546

First received: November 24, 2010

Last updated: February 4, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	November 24, 2010
Last Updated Date	February 4, 2013
Start Date ^ICMJE	November 2010
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 4, 2013)	Screening performance indicators [ Time Frame: From Nov. 22, 2010 to Dec. 31, 2012 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01248546 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 4, 2013)	Interval cancer rate [ Time Frame: From Nov. 23, 2010 to Dec. 31, 2014 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Tomosynthesis in the Oslo Breast Cancer Screening Program
Official Title ^ICMJE	Digital Breast Tomosynthesis in the Oslo Mammography Screening Program
Brief 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. 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
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
Condition ^ICMJE	Recall Rate Cancer Detection Rate False Positive Rate Positive Predictive Value
Intervention ^ICMJE	Procedure: Digital breast tomosynthesis The participants included in the trial will have an additional radiation exposure for breast tomosynthesis
Study Group/Cohort (s)	Digital mammography Intervention: Procedure: Digital breast tomosynthesis
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	25000
Estimated Completion Date	September 2015
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Women 50 to 69 years who have signed the informed consent Exclusion Criteria: Women with pacemaker, implants, and severely disabled
Gender	Female
Ages	50 Years to 69 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Norway

Administrative Information
NCT Number ^ICMJE	NCT01248546
Other Study ID Numbers ^ICMJE	2010/144 (REK)
Has Data Monitoring Committee	No
Responsible Party	Per Skaane, Oslo University Hospital
Study Sponsor ^ICMJE	Oslo University Hospital
Collaborators ^ICMJE	The Norwegian Cancer Registry Hologic, Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	Oslo University Hospital
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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