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Trial record 1 of 1 for:    The Tomosynthesis Trial in Bergen, part 2
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The Tomosynthesis Trial in Bergen - Part 2 (To-Be 2)

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ClinicalTrials.gov Identifier: NCT03669926
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 14, 2018
Sponsor:
Collaborators:
Haukeland University Hospital
University of Oslo
Norwegian Cancer Society
Information provided by (Responsible Party):
Cancer Registry of Norway

Brief Summary:
The aim of the study is to compare early performance measures and economic aspects of organized breast cancer screening for women screened using digital breast tomosynthesis+synthetic mammography (DBT+SM) to women with a prior DBT+SM or digital mammography (DM) from To-Be 1 (NCT02835625).

Condition or disease Intervention/treatment Phase
Breast Neoplasms Radiation: Digital Breast Tomosynthesis+synthetic mammography Not Applicable

Detailed Description:

Digital breast tomosynthesis (DBT) is a new "three-dimensional" screening tool for breast cancer, claimed to be superior to standard two-dimensional (2D) digital mammography (DM) based on results of lower or similar recall rate, and a 30-50% higher rate of screen-detected breast cancer for DBT compared to DM.

The Bergen Tomosynthesis Trial (To-Be) is a randomized controlled trial investigating whether DBT, including synthetic mammography (SM), is superior for breast cancer screening to DM (ClinicalTrials.gov Identifier: NCT02835625) - hereafter referred to as To-Be 1. The study is run as part of BreastScreen Norway (inviting women aged 50-69 to screening every two years). It started in October 2015 and finished recruitment in December 2017, after two years - one screening round - of data collection.

Results from To-Be 1 will fill some of the knowledge gaps regarding DBT+SM in screening. However, running To-Be 1 and recent publications on the topic have identified additional challenges and new evidence gaps that are important to address before DBT can be considered for use in organized screening. Thus, the To-Be trail will be extended with five more year (To-Be 2), consisting of one additional screening round (two years) where all women in the study population are screened with DBT+SM with a three year follow-up.

To investigate the effect of subsequent screening with DBT+SM all women attending mammography screening in Bergen in 2018 and 2019 will be screened with DBT+SM. To-Be 2 is a prospective cohort study targeting 32 000 women, and all women attending screening will be asked if they are willing to take part in the study after receiving written and oral information about the study. Women willing to participate in the study will sign an informed consent form. We expect a participation rate of 90%. The participating women will be screened with DBT+SM. Women not willing to participate in the study will be screened with DM, and not included in our study.

Continuing To-Be 1 with To-Be 2 is the only opportunity to get information on women subsequently screened with DBT+SM, that have a prior DBT+SM or DM based on random allocation. This will also allow the investigators to analyze data on interval breast cancer among women screened with DBT+SM after DBT+SM and with DBT+SM after DM in To-Be 1 in 2020.

The investigators aim to address the following topics and research questions:

Part I: Early performance measures for screening with DBT+SM after DBT+SM, and DBT+SM after DM.

Part II: Interval breast cancer following screening with DBT+SM versus DM, focusing on interval breast cancers identified among women screened in To-Be 1.

Part III: Missed and true screen-detected and interval breast cancer in mammographic screening with DBT+SM versus DM.

Part IV: Expected and experienced discomfort and pain in DBT+SM by compression force and pressure.

Part V: Economic evaluation of continuous use of DBT.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Digital Breast Tomosynthesis - The Future Screening Tool for Breast Cancer?
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
DBT+SM
Digital Breast Tomosynthesis+synthetic mammography (DBT+SM) All women are screened with DBT+SM. All examinations are independently double read. Consensus used to decide whether or not to recall.
Radiation: Digital Breast Tomosynthesis+synthetic mammography
Two-view tomosynthesis performed with GE Senographe Pristina.
Other Name: DBT+SM




Primary Outcome Measures :
  1. Compare rates of screen detected breast cancer after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. [ Time Frame: 48 months from start up of the trial ]
    Rate of screening detected breast cancer, among those screened


Secondary Outcome Measures :
  1. Compare recall rates after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. [ Time Frame: 48 months from start up of the trial ]
    Rate of recalled women due to mammographic findings, among those screened

  2. Positive predictive value of recalls after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. [ Time Frame: 48 months from start up of the trial ]
    Rate of breast cancer cases among those recalled

  3. Prognostic and predictive tumor characteristics for screening detected breast cancer after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. [ Time Frame: 48 months from start up of the trial ]
    Distribution of characteristics among the women diagnosed with breast cancer

  4. Rate of interval breast cancer following screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. [ Time Frame: 48 months from start up of the trial ]
    Rates and prognostic and predictive tumor characteristics of interval cancer among women screened in To-Be 1, stratified by mammographic density.

  5. Rate of missed and true screen-detected and interval breast cancer in mammographic screening with DBT+SM versus DM. [ Time Frame: 24-48 month after start up of the trial ]
    Retrospective review of prior and actual mammograms from women with interval and screen-detected breast cancers detected in To-Be 1 and 2, respectively.

  6. Economical aspects of continuous use of DBT+SM [ Time Frame: 48 months from start up of the trial ]
    Estimation of the financial impact of running a screening program with DBT+SM in an everyday setting.

  7. Comparing interpretation times to investigate possible learning effects when reading DBT+SM in two consecutive screening rounds [ Time Frame: 48 months from start up of the trial ]
    Evaluation of difference in interpretation time for subsequent versus prevalent DBT+SM screens

  8. Assessing degree of experienced and expected pain in DBT+SM screening by compression pressure using questionnaire [ Time Frame: 6 to 48 months after start up of the trial ]
    Explore whether individualized, standardized compression pressure influences women's screening experiences using a numeric rating scale (0 "No discomfort/pain" to 10 "Very much discomfort/pain"). Drafting of the questionnaire is in progress.



Information from the National Library of Medicine

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Ages Eligible for Study:   48 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women are invited to breast cancer screening in BreastScreenn Norway.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written, informed consent to participation

Exclusion Criteria:

  • No written, informed consent to participation
  • Breast implants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03669926


Contacts
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Contact: Solveig Hofvind, Professor +4722928828 solveig.hofvind@kreftregisteret.no
Contact: Åsne S Holen, MSc +4722928760 asne.holen@kreftregisteret.no

Locations
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Norway
Cancer Registry of Norway Recruiting
Oslo, Norway, 0379
Contact: Solveig Hofvind    +47 22928828    solveig.hofvind@kreftregisteret.no   
Contact: Åsne Holen    +47 22928760    asne.holen@kreftregisteret.no   
Sponsors and Collaborators
Cancer Registry of Norway
Haukeland University Hospital
University of Oslo
Norwegian Cancer Society
Investigators
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Principal Investigator: Solveig Hofvind, Professor Cancer Registry of Norway

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Responsible Party: Cancer Registry of Norway
ClinicalTrials.gov Identifier: NCT03669926     History of Changes
Other Study ID Numbers: 17/209
190184-2017 ( Other Grant/Funding Number: Norwegian Cancer Society )
First Posted: September 13, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not share the data outside the project group

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cancer Registry of Norway:
Diagnostic Imaging
Mammography
Tomosynthesis
Breast cancer screening
Subsequent screening
Cancer detection
Cost effectiveness
Early performance measures
Interval cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases