Spots Global Cancer Trial Database for Breast Cancer Screening: Digital Breast Tomosynthesis Versus Digital 2D Mammography
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Trial Identification
Brief Title: Breast Cancer Screening: Digital Breast Tomosynthesis Versus Digital 2D Mammography
Official Title: Prospective Randomized Comparison of Digital Breast Tomosynthesis Plus Synthesized Images Versus Standard Full-field Digital Mammography in Population-based Screening (TOSYMA)
Study ID: NCT03377036
Conditions
Study Description
Brief Summary: This study is a randomized, multicenter, multivendor, controlled, diagnostic superiority trial to compare digital breast tomosynthesis plus synthesized 2D mammograms (DBT+s2D) versus standard 2D full-field digital mammography (2D-FFDM) regarding the effectiveness as screening modality.
Detailed Description: The primary objective of the study is to evaluate whether digital breast tomosynthesis plus synthesized 2D mammograms leads to a relevant increase in the detection rate of screening-detected invasive cancers compared to 2D full-field digital mammography in routine screening according to the European Guidelines. Furthermore, the incidence rate of interval cancers within a 24 months interval after screening will be compared between both study arms in order to investigate the potential for overdiagnosis. According to the pre-defined order of both primary endpoints and the primary objective of the study in the planning phase, the initial sample size calculation was based solely on the first primary endpoint (invasive breast cancer detection rate). Given the increasing national and international attention of interval cancers to assess the impact of potential overdiagnosis caused by tomosynthesis, we have planned a sample size increase from 80,000 to 120,000 study participants to achieve a reasonable statistical power for the evaluation of both primary endpoints. The revised sample size calculation was carried out without knowledge of the data from the currently recruiting TOSYMA study, i.e. all planning assumptions were based on external data that do not belong to the ongoing study.
Eligibility
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
Screening-Einheit Hannover; Mammographie-Einheit Hannover, Hannover, Niedersachsen, Germany
Screening-Einheit Niedersachsen Nordost; Mammographie-Einheit Lüneburg, Lüneburg, Niedersachsen, Germany
Screening-Einheit Niedersachsen Nord; Mammographie-Einheit Stade, Stade, Niedersachsen, Germany
Screening-Einheit Niedersachsen Mitte; Mammographie-Einheit Vechta, Vechta, Niedersachsen, Germany
Screening-Einheit Niedersachsen Nordwest; Mammographie-Einheit Wilhelmshaven, Wilhelmshaven, Niedersachsen, Germany
Screening-Einheit Aachen-Düren-Heinsberg; Mammographie-Einheit Aachen, Aachen, Nordrhein-Westfalen, Germany
Referenz-Screening-Einheit Münster-Nord/Warendorf; Mammographie-Einheit Ahlen, Ahlen, Nordrhein-Westfalen, Germany
Screening-Einheit Köln rechtsrheinisch, Leverkusen, Rhein.-Berg. Kreis, Oberbergischer Kreis; Mammographie-Einheit Bergisch Gladbach, Bergisch Gladbach, Nordrhein-Westfalen, Germany
Screening-Einheit Bielefeld, Gütersloh; Mammographie-Einheit Bielefeld, Bielefeld, Nordrhein-Westfalen, Germany
Screening-Einheit Münster-Süd; Mammographie-Einheit Coesfeld, Coesfeld, Nordrhein-Westfalen, Germany
Screening-Einheit Duisburg; Mammographie-Einheit Duisburg, Duisburg, Nordrhein-Westfalen, Germany
Screening-Einheit Gelsenkirchen, Kreis Recklinghausen, Bottrop; Mammographie-Einheit Gelsenkirchen, Gelsenkirchen, Nordrhein-Westfalen, Germany
Screening-Einheit Minden-Lübbecke, Herford; Mammographie-Einheit Herford, Herford, Nordrhein-Westfalen, Germany
Screening-Einheit Mönchengladbach, Krefeld, Viersen; Mammographie-Einheit Krefeld, Krefeld, Nordrhein-Westfalen, Germany
Screening-Einheit Höxter, Paderborn, Soest; Mammographie-Einheit Lippstadt, Lippstadt, Nordrhein-Westfalen, Germany
Referenz-Screeening-Einheit Münster-Nord/Warendorf; Mammographie-Einheit Münster-Nord, Münster, Nordrhein-Westfalen, Germany
Screening-Einheit Münster-Süd; Mammographie-Einheit Münster, Münster, Nordrhein-Westfalen, Germany
Screening-Einheit Höxter, Paderborn, Soest; Mammographie-Einheit Paderborn, Paderborn, Nordrhein-Westfalen, Germany
Screening-Einheit Märkischer Kreis, Hamm, Unna; Mammographie-Einheit Schwerte, Schwerte, Nordrhein-Westfalen, Germany
Screening-Einheit Raum Bergisch Land/Kreis Mettmann; Mammographie-Einheit Solingen-Mitte, Solingen, Nordrhein-Westfalen, Germany
Screening-Einheit Raum Bergisch Land/Kreis Mettmann; Mammographie-Einheit Wuppertal-Elberfeld, Wuppertal, Nordrhein-Westfalen, Germany
Contact Details
Name: Walter Heindel, MD, PhD
Affiliation: University Clinic for Radiology, University of Muenster / University Hospital Muenster
Role: PRINCIPAL_INVESTIGATOR
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