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Tomosynthesis in the Oslo Breast Cancer Screening Program (DBT)

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ClinicalTrials.gov Identifier: NCT01248546
Recruitment Status : Unknown
Verified February 2013 by Per Skaane, Oslo University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2010
Last Update Posted : February 5, 2013
Sponsor:
Collaborators:
Cancer Registry of Norway
Hologic, Inc.
Information provided by (Responsible Party):
Per Skaane, Oslo University Hospital

Tracking Information
First Submitted Date November 24, 2010
First Posted Date November 25, 2010
Last Update Posted Date February 5, 2013
Study Start Date November 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 4, 2013)
Screening performance indicators [ Time Frame: From Nov. 22, 2010 to Dec. 31, 2012 ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: February 4, 2013)
Interval cancer rate [ Time Frame: From Nov. 23, 2010 to Dec. 31, 2014 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Tomosynthesis in the Oslo Breast Cancer Screening Program
Official Title 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 Observational
Study Design 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
  • Recall Rate
  • Cancer Detection Rate
  • False Positive Rate
  • Positive Predictive Value
Intervention Procedure: Digital breast tomosynthesis
The participants included in the trial will have an additional radiation exposure for breast tomosynthesis
Study Groups/Cohorts Digital mammography
Intervention: Procedure: Digital breast tomosynthesis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 24, 2010)
25000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2015
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Women 50 to 69 years who have signed the informed consent

Exclusion Criteria:

  • Women with pacemaker, implants, and severely disabled
Sex/Gender
Sexes Eligible for Study: Female
Ages 50 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT01248546
Other Study ID Numbers 2010/144 (REK)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Per Skaane, Oslo University Hospital
Study Sponsor Oslo University Hospital
Collaborators
  • Cancer Registry of Norway
  • Hologic, Inc.
Investigators Not Provided
PRS Account Oslo University Hospital
Verification Date February 2013