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TOBE: The Digital Breast Tomosynthesis Trial in Bergen

Sponsor
Cancer Registry of Norway (Other)
Overall Status
Completed
CT.gov ID
NCT02835625
Collaborator
Haukeland University Hospital (Other), University of Oslo (Other), The Research Council of Norway (Other)
29,453
Enrollment
2
Locations
2
Arms
64
Actual Duration (Months)
14726.5
Patients Per Site
230.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Compare synthetic mammography+digital breast tomosynthesis (SM+DBT) with digital mammography (DM) as a screening tool for women aged 50-69 years, invited to participate in the Norwegian Breast Cancer Screening Program at the screening unit in Bergen, Norway, with regard to early performance measures, including prognostic and predictive tumor characteristics, radiation doses and cost-effectiveness.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Synthetic Mammography + Digital Breast Tomosynthesis
  • Radiation: Digital mammography
 N/A

Detailed Description

DBT is a new screening tool, argued to be better than standard DM. This statement is based on a lower recall rate, and a higher rate of early-stage screen-detected cancer. No studies have so far reported results from women screened with DBT from GE Healthcare, as far as the investigators know. DBT from GE offer synthetic two-dimensional DM generated from the DBT data (SM), and studies have shown similar detection rates for this technique as of adjacent DM. By comparing results of early performance measures and economic aspects in two comparable populations of women in the same age group, residing in the same county, the investigators can measure the effect of SM+DBT versus standard DM with equipment from GE Healthcare. The populations will be examined by the same radiographers, screen-read by the same radiologists, histologically breast cancer proven by the same pathologists, and treated by the same surgeons and oncologists.

A prospective cohort study targeting 45,000 women invited to breast cancer screening in Bergen, Hordaland in the study period, 2016-2018, will be performed. A screening participation of approximately 75% is expected. All attending women will be asked if they are willing to participate in the study after receiving written and oral information about the study. Women willing to participate in the study will sign an informed consent. Of the attending women it is expected that about 90-95% will consent to participate in the study. The women will be randomized into two groups, a study group and a control group. The randomization will take place at the screening unit in Bergen. The outcome of the randomization is based on the 11-digit personal identification number assigned to every citizen in Norway. In the study group, the women will be screened with SM+DBT. In the control group, the women will be screened with DM. Women not willing to participate in the study will be screened with DM, and not included in our study.

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

  • Study 1: Early performance measures in a population based screening program using SM+DBT versus DM - interim analyses.

  • Study 2: Use of SM+DBT versus DM in a population based screening program - a randomized controlled trial.

  • Study 3: Prognostic and predictive histopathologic characteristics of breast tumors detected in a population based program using SM+DBT versus DM.

  • Study 4: SM+DBT and DM in a populations based screening program - which technology has the highest sensitivity for women with mammographic dense breast?

  • Study 5 and 6: Costs of SM+DBT and DM in a populations based screening program - is SM+DBT cost-effective?

Study Design

Study Type:
Interventional
Actual Enrollment :
29453 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Digital Breast Tomosynthesis - The Future Screening Tool for Breast Cancer?
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Digital Breast Tomosynthesis

Synthetic Mammography (SM) + Digital Breast Tomosynthesis (DBT) The SM+DBT will be independently read by two radiologists. A consensus meeting will decide whether to recall the woman or not. Women selected for further assessment (positive screening exam) will be recalled.

Radiation: Synthetic Mammography + Digital Breast Tomosynthesis
Two-view tomosynthesis performed with GE Senoclaire 3D Breast Tomosynthesis.
Other Names:
  • SM+DBT

    		•
    Active Comparator: Digital mammography

    The digital mammograms will be independently read by two radiologists. A consensus meeting will decide whether to recall the woman or not.

    Radiation: Digital mammography
    Two-view digital mammography performed with GE Senoclaire 3D Breast Tomosynthesis.
    Other Names:
  • DM

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Screen-Detected Breast Cancer [36 months from start up of the trial]

      Comparison of rates of screen-detected breast cancer in tomosynthesis versus digital mammography as performed in a population based screening program.

    Secondary Outcome Measures

    1. Number and Percentage of Participants Screen-Detected Breast Cancer Among Participants Recalled for Further Assesment [36 months from start up of the trial]

      Positive predictive value of recalls (number of screen-detected breast cancer among participants recalled for further assesment) for tomosynthesis versus digital mammography in a population based screening program.

    2. Number of Participants Recalled for Further Assesment Due to Mammographic Findings [36 months from start up of the trial]

      Comparison of rate of recall for further assesment due to mammographic findings in tomosynthesis versus digital mammography as performed in a population based screening program.

    3. Incremental Costs of Screening With Tomosynthesis Versus Digital Mammography [36 months from start up of the trial]

      The incremental cost per woman screened with digital breast tomosynthesis versus digital mammography in a population-based breast cancer screening program.

    4. Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer [36 months from start up of the trial]

      Distribution of characteristics among the women diagnosed with breast cancer screened with tomosynthesis versus digital mammography in a population based screening program.

    5. Number of Participants With Interval Breast Cancer [60 months from start up of the trial]

      Rate of interval breast cancer among those screened with tomosynthesis versus digital mammography as performed in a population based screening program.

    Other Outcome Measures

    1. Time Spent on Screen-Reading and Consensus Meetings [24 months from start up of the trial]

      The time spent on screen-reading and consensus will be compared for tomosynthesis versus digital mammography

    2. Mammographic Features of Screen-Detected Breast Cancer [36 months from start up of the trial]

      Distribution of characteristics among the women diagnosed with breast cancer screened with tomosynthesis versus digital mammography in a population based screening program.

    3. Radiation Doses When Screening With Tomosynthesis Versus Digital Mammography [24 months from start up of the trial]

      Radiation doses will be measured for screening with tomosynthesis and digital mammography by an automated software, in milligray (mGy).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    48 Years to 71 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Informed consent
    Exclusion Criteria:
    • Breast implants

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Haukeland University Hospital Bergen Hordaland Norway 0521
    2 Cancer Registry of Norway Oslo Norway 0379

    Sponsors and Collaborators

    • Cancer Registry of Norway
    • Haukeland University Hospital
    • University of Oslo
    • The Research Council of Norway

    Investigators

    • Principal Investigator: Solveig Hofvind, Professor, Cancer Registry of Norway

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Cancer Registry of Norway
    ClinicalTrials.gov Identifier:
    NCT02835625
    Other Study ID Numbers:
    • 247941/H10
    First Posted:
    Jul 18, 2016
    Last Update Posted:
    Jul 30, 2021
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Cancer Registry of Norway
    Diagnostic Imaging
    Mammography
    Randomized Controlled Trial
    Tomosynthesis
    Early performance measures
    Recall
    Radiation dose
    Cancer detection
    Sensitivity
    Specificity
    Cost
    Economy
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    Participant Flow

    Recruitment Details Women were invited to participate when attending screening at the screening unit Danmarksplass in Bergen, Norway. The recruitment period lasted from January 14th 2016 to December 15th 2017.
    Pre-assignment Detail Women that attended screening but had breast implant were not invited to participate, and thus not randomized to either of the study groups.
    Arm/Group Title Digital Breast Tomosynthesis Digital Mammography
    Arm/Group Description Digital Breast Tomosynthesis + Synthetic Mammography (DBT) The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis. The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.
    Period Title: Overall Study
    STARTED 14734 14719
    COMPLETED 14734 14719
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Digital Breast Tomosynthesis Digital Mammography Total
    Arm/Group Description Digital Breast Tomosynthesis + Synthetic Mammography (DBT) The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis. The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis. Total of all reporting groups
    Overall Participants 14380 14369 28749
    Age, Customized (Count of Participants)
    <55 years
    3746
    26.1%
    3813
    26.5%
    7559
    26.3%
    55-59 years
    3628
    25.2%
    3668
    25.5%
    7296
    25.4%
    60-64 years
    3625
    25.2%
    3492
    24.3%
    7117
    24.8%
    >64 years
    3381
    23.5%
    3396
    23.6%
    6777
    23.6%
    Sex: Female, Male (Count of Participants)
    Female
    14380
    100%
    14369
    100%
    28749
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (participants) [Number]
    Norway
    14380
    100%
    14369
    100%
    28749
    100%
    Screening history (Count of Participants)
    Prevalent (first screening)
    2013
    14%
    2053
    14.3%
    4066
    14.1%
    Subsequent
    12367
    86%
    12316
    85.7%
    24683
    85.9%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Screen-Detected Breast Cancer
    Description Comparison of rates of screen-detected breast cancer in tomosynthesis versus digital mammography as performed in a population based screening program.
    Time Frame 36 months from start up of the trial

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Digital Breast Tomosynthesis Digital Mammography
    Arm/Group Description Digital Breast Tomosynthesis + Synthetic Mammography (DBT) The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis. The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.
    Measure Participants 14380 14369
    Count of Participants [Participants]
    95
    0.7%
    87
    0.6%
    2. Secondary Outcome
    Title Number and Percentage of Participants Screen-Detected Breast Cancer Among Participants Recalled for Further Assesment
    Description Positive predictive value of recalls (number of screen-detected breast cancer among participants recalled for further assesment) for tomosynthesis versus digital mammography in a population based screening program.
    Time Frame 36 months from start up of the trial

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Digital Breast Tomosynthesis Digital Mammography
    Arm/Group Description Digital Breast Tomosynthesis + Synthetic Mammography (DBT) The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis. The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.
    Measure Participants 444 571
    Count of Participants [Participants]
    95
    0.7%
    87
    0.6%
    3. Secondary Outcome
    Title Number of Participants Recalled for Further Assesment Due to Mammographic Findings
    Description Comparison of rate of recall for further assesment due to mammographic findings in tomosynthesis versus digital mammography as performed in a population based screening program.
    Time Frame 36 months from start up of the trial

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Digital Breast Tomosynthesis Digital Mammography
    Arm/Group Description Digital Breast Tomosynthesis + Synthetic Mammography (DBT) The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis. The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.
    Measure Participants 14380 14369
    Count of Participants [Participants]
    444
    3.1%
    571
    4%
    4. Secondary Outcome
    Title Incremental Costs of Screening With Tomosynthesis Versus Digital Mammography
    Description The incremental cost per woman screened with digital breast tomosynthesis versus digital mammography in a population-based breast cancer screening program.
    Time Frame 36 months from start up of the trial

    Outcome Measure Data

    Analysis Population Description
    For each participant, the incremental cost of tomosynthesis vs. digital mammography were estimated, not the total cost of tomosynthesis vs. digital mammography. The investigators assumed that costs not pertaining to examination and reading times, mammograph price, IT storage and connectivity were equal for the two. This Outcome Measure was pre-specified to present the incremental costs per screened woman. By nature, incremental costs are calculated between groups.
    Arm/Group Title Digital Breast Tomosynthesis Versus Digital Mammography
    Arm/Group Description Comparing costs of procedure use and screening, recall and treatment costs estimated at the individual level for Digital Breast Tomosynthesis + Synthetic Mammography (DBT) versus Digital Mammography (DM).
    Measure Participants 29453
    Incremental costs of DBT vs. DM in Euro
    8.5
    Incremental cost of DBT vs. DM after adding costs of recall, in Euro
    6.2
    5. Secondary Outcome
    Title Prognostic and Predictive Tumor Characteristics for Screen-Detected Breast Cancer
    Description Distribution of characteristics among the women diagnosed with breast cancer screened with tomosynthesis versus digital mammography in a population based screening program.
    Time Frame 36 months from start up of the trial

    Outcome Measure Data

    Analysis Population Description
    When collecting information on histopathological tumor characteristics, not all participants had information available on all variables.
    Arm/Group Title Digital Breast Tomosynthesis Digital Mammography
    Arm/Group Description Digital Breast Tomosynthesis + Synthetic Mammography (DBT) The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis. The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.
    Measure Participants 80 71
    Histological type : Carcinoma (no special type)
    62
    0.4%
    51
    0.4%
    Histological type : Lobular carcinoma
    6
    0%
    13
    0.1%
    Histological type : Tubular carcinoma
    2
    0%
    4
    0%
    Histological type : Other carcinoma
    10
    0.1%
    3
    0%
    Tumor diameter : <10 mm
    10
    0.1%
    18
    0.1%
    Tumor diameter : >=10-<20 mm
    43
    0.3%
    29
    0.2%
    Tumor diameter : >=20 mm
    17
    0.1%
    13
    0.1%
    Lymph node positive
    14
    0.1%
    18
    0.1%
    Histological grade : grade 1
    22
    0.2%
    24
    0.2%
    Histological grade : grade 2
    38
    0.3%
    35
    0.2%
    Histological grade : grade 3
    16
    0.1%
    10
    0.1%
    Estrogen receptor positive
    71
    0.5%
    69
    0.5%
    Progesterone receptor positive
    61
    0.4%
    62
    0.4%
    HER2 positive
    8
    0.1%
    8
    0.1%
    Ki67 >=30%
    21
    0.1%
    13
    0.1%
    6. Secondary Outcome
    Title Number of Participants With Interval Breast Cancer
    Description Rate of interval breast cancer among those screened with tomosynthesis versus digital mammography as performed in a population based screening program.
    Time Frame 60 months from start up of the trial

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Digital Breast Tomosynthesis Digital Mammography
    Arm/Group Description Digital Breast Tomosynthesis + Synthetic Mammography (DBT) The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis. The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.
    Measure Participants 14380 14369
    Count of Participants [Participants]
    20
    0.1%
    29
    0.2%
    7. Other Pre-specified Outcome
    Title Time Spent on Screen-Reading and Consensus Meetings
    Description The time spent on screen-reading and consensus will be compared for tomosynthesis versus digital mammography
    Time Frame 24 months from start up of the trial

    Outcome Measure Data

    Analysis Population Description
    Interim analysis performed on study population from the first year of the trial (2016). All cases were screen-read by two radiologist, however not all were discussed at consensus.
    Arm/Group Title Digital Breast Tomosynthesis Digital Mammography
    Arm/Group Description Digital Breast Tomosynthesis + Synthetic Mammography (DBT) The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis. The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.
    Measure Participants 7037 7052
    Initial screen reading
    70.5
    (54.4)
    41.3
    (49.6)
    Consensus reading
    192.1
    (118.1)
    131.9
    (79.2)
    8. Other Pre-specified Outcome
    Title Mammographic Features of Screen-Detected Breast Cancer
    Description Distribution of characteristics among the women diagnosed with breast cancer screened with tomosynthesis versus digital mammography in a population based screening program.
    Time Frame 36 months from start up of the trial

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Digital Breast Tomosynthesis Digital Mammography
    Arm/Group Description Digital Breast Tomosynthesis + Synthetic Mammography (DBT) The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis. The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.
    Measure Participants 95 87
    Spiculated mass
    35
    0.2%
    16
    0.1%
    Indistinct mass
    16
    0.1%
    16
    0.1%
    Calcifications
    13
    0.1%
    20
    0.1%
    Architectural distortion
    10
    0.1%
    7
    0%
    Asymmetry
    7
    0%
    12
    0.1%
    Mass with calcifications
    7
    0%
    11
    0.1%
    Circumscribed mass
    5
    0%
    2
    0%
    Obscured mass
    1
    0%
    3
    0%
    Associated features
    1
    0%
    0
    0%
    9. Other Pre-specified Outcome
    Title Radiation Doses When Screening With Tomosynthesis Versus Digital Mammography
    Description Radiation doses will be measured for screening with tomosynthesis and digital mammography by an automated software, in milligray (mGy).
    Time Frame 24 months from start up of the trial

    Outcome Measure Data

    Analysis Population Description
    Interim analysis performed on study population from the first year of the trial (2016). Not all women had available information on radiation dose.
    Arm/Group Title Digital Breast Tomosynthesis Digital Mammography
    Arm/Group Description Digital Breast Tomosynthesis + Synthetic Mammography (DBT) The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis. The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.
    Measure Participants 6957 6972
    Mean (Standard Deviation) [mGy]
    2.96
    (0.62)
    2.95
    (0.38)

    Adverse Events

    Time Frame Participant were followed for two years after the recruitment period for the study ended (December 31st 2017) to collect data on adverse events. Reporting of adverse events are not yet complete as we rely on data from the Norwegian Cause of Death Registry.
    Adverse Event Reporting Description
    Arm/Group Title Digital Breast Tomosynthesis Digital Mammography
    Arm/Group Description Digital Breast Tomosynthesis + Synthetic Mammography (DBT) The DBT was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital Breast Tomosynthesis + Synthetic Mammography: Two-view tomosynthesis performed with GE SenoClaire 3D Breast Tomosynthesis. The digital mammograms was independently read by two radiologists. A consensus meeting decided whether to recall the woman or not. Women selected for further assessment (positive screening exam) was recalled. Digital mammography: Two-view digital mammography performed with GE SenoClaire 3D Breast Tomosynthesis.
    All Cause Mortality
    Digital Breast Tomosynthesis Digital Mammography
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/14734 (0%) 2/14719 (0%)
    Serious Adverse Events
    Digital Breast Tomosynthesis Digital Mammography
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/14734 (0%) 0/14719 (0%)
    Other (Not Including Serious) Adverse Events
    Digital Breast Tomosynthesis Digital Mammography
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/14734 (0%) 0/14719 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Prof. Solveig Hofvind
    Organization Cancer Registry of Norway
    Phone +47 22928828
    Email solveig.hofvind@kreftregisteret.no
    Responsible Party:
    Cancer Registry of Norway
    ClinicalTrials.gov Identifier:
    NCT02835625
    Other Study ID Numbers:
    • 247941/H10
    First Posted:
    Jul 18, 2016
    Last Update Posted:
    Jul 30, 2021
    Last Verified:
    Jan 1, 2020