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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

Interventions

DBT+s2D
2D-FFDM

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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