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| ID | Type | Description | Link |
|---|---|---|---|
| HE1646/5-1 and HE1646/5-2 | Other Grant/Funding Number | German Research Foundation (DFG) |
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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBT+s2D | Experimental | Digital breast tomosynthesis plus synthesized 2D mammograms |
|
| 2D-FFDM | Active Comparator | 2D full-field digital mammography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBT+s2D | Diagnostic Test | Digital breast tomosynthesis plus synthesized 2D mammograms |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate of invasive breast cancers | Number of women with screening-detected invasive breast cancer divided by the number of all women screened. A screening-detected breast cancer is classified as invasive carcinoma if the pT category (pathological tumor size) of the TNM classification falls into one of the following categories: pT1mic, pT1a, pT1b, pT1c, pT1, pT2, pT3, pT4a, pT4b, pT4c, pT4d, pT4, pTX (for evaluation purpose pTX defines histologically approved invasive breast cancer with missing tumor diameter) or the final pathological categorization has been done after neoadjuvant therapy (ypT), implying an invasive cancer prior to therapy. | Routine screening visit |
| Cumulative 24 months incidence of interval cancers | The 24 months incidence of interval cancers is defined as the number of women that develop a ductal carcinoma in situ or an invasive breast cancer in the 24 months interval after a negative screening examination divided by the number of all women with a negative screening result. | 24 months after routine screening visit |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate of ductal carcinoma in situ (DCIS) | Number of women with screening-detected ductal carcinoma in situ (if the pT category of the TNM classification falls into the category pTis) divided by the number of all women screened. | Routine screening visit |
| Detection rate of tumor category pT1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walter Heindel, MD, PhD | University Clinic for Radiology, University of Muenster / University Hospital Muenster | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Screening-Einheit Hannover; Mammographie-Einheit Hannover | Hanover | Lower Saxony | 30449 | Germany | ||
| Screening-Einheit Niedersachsen Nordost; Mammographie-Einheit Lüneburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29764880 | Background | Weigel S, Gerss J, Hense HW, Krischke M, Sommer A, Czwoydzinski J, Lenzen H, Kerschke L, Spieker K, Dickmaenken S, Baier S, Urban M, Hecht G, Heidinger O, Kieschke J, Heindel W. Digital breast tomosynthesis plus synthesised images versus standard full-field digital mammography in population-based screening (TOSYMA): protocol of a randomised controlled trial. BMJ Open. 2018 May 14;8(5):e020475. doi: 10.1136/bmjopen-2017-020475. | |
| 40956160 |
| Label | URL |
|---|---|
| BMJ Open | View source |
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Participants will be randomized to either Digital Breast Tomosynthesis plus synthesized 2D mammograms (DBT+s2D) or 2D Full-Field Digital Mammography (2D-FFDM)
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| 2D-FFDM |
| Diagnostic Test |
2D full-field digital mammography |
|
Number of women with screening-detected invasive breast cancers of the category pT1 divided by the number of all women screened. A screening-detected breast cancer is classified as breast cancer of tumor category pT1 if tumor size is ≤ 20 mm in greatest dimension and the respective pT subcategory of the pTNM classification is one of the following: pT1mic, pT1a, pT1b, pT1c, pT1. |
| Routine screening visit |
| Recall rate for further assessment | Number of women with recalls for further assessment divided by the number of all women screened. | Routine Screening Visit |
| Positive predictive value of recall for further assessment (PPV1) | Number of women with screening-detected malignancies (ductal carcinoma in situ or invasive breast cancer) divided by the number of women with recalls for further assessment. | Routine screening visit |
| Cumulative 12 months incidence of interval cancers | The 12 months incidence of interval cancers is defined as the number of women that develop a ductal carcinoma in situ or an invasive breast cancer in the 12 months interval after a negative screening examination divided by the number of all women with a negative screening result. | 12 months after routine screening visit |
| Lüneburg |
| Lower Saxony |
| 21337 |
| Germany |
| Screening-Einheit Niedersachsen Nord; Mammographie-Einheit Stade | Stade | Lower Saxony | 21680 | Germany |
| Screening-Einheit Niedersachsen Mitte; Mammographie-Einheit Vechta | Vechta | Lower Saxony | 49377 | Germany |
| Screening-Einheit Niedersachsen Nordwest; Mammographie-Einheit Wilhelmshaven | Wilhelmshaven | Lower Saxony | 26382 | Germany |
| Screening-Einheit Aachen-Düren-Heinsberg; Mammographie-Einheit Aachen | Aachen | North Rhine-Westphalia | 52062 | Germany |
| Referenz-Screening-Einheit Münster-Nord/Warendorf; Mammographie-Einheit Ahlen | Ahlen | North Rhine-Westphalia | 59227 | Germany |
| Screening-Einheit Köln rechtsrheinisch, Leverkusen, Rhein.-Berg. Kreis, Oberbergischer Kreis; Mammographie-Einheit Bergisch Gladbach | Bergisch Gladbach | North Rhine-Westphalia | 51429 | Germany |
| Screening-Einheit Bielefeld, Gütersloh; Mammographie-Einheit Bielefeld | Bielefeld | North Rhine-Westphalia | 33062 | Germany |
| Screening-Einheit Münster-Süd; Mammographie-Einheit Coesfeld | Coesfeld | North Rhine-Westphalia | 48653 | Germany |
| Screening-Einheit Duisburg; Mammographie-Einheit Duisburg | Duisburg | North Rhine-Westphalia | 47057 | Germany |
| Screening-Einheit Gelsenkirchen, Kreis Recklinghausen, Bottrop; Mammographie-Einheit Gelsenkirchen | Gelsenkirchen | North Rhine-Westphalia | 45894 | Germany |
| Screening-Einheit Minden-Lübbecke, Herford; Mammographie-Einheit Herford | Herford | North Rhine-Westphalia | 32052 | Germany |
| Screening-Einheit Mönchengladbach, Krefeld, Viersen; Mammographie-Einheit Krefeld | Krefeld | North Rhine-Westphalia | 47805 | Germany |
| Screening-Einheit Höxter, Paderborn, Soest; Mammographie-Einheit Lippstadt | Lippstadt | North Rhine-Westphalia | 59555 | Germany |
| Referenz-Screeening-Einheit Münster-Nord/Warendorf; Mammographie-Einheit Münster-Nord | Münster | North Rhine-Westphalia | 48143 | Germany |
| Screening-Einheit Münster-Süd; Mammographie-Einheit Münster | Münster | North Rhine-Westphalia | 48153 | Germany |
| Screening-Einheit Höxter, Paderborn, Soest; Mammographie-Einheit Paderborn | Paderborn | North Rhine-Westphalia | 33098 | Germany |
| Screening-Einheit Märkischer Kreis, Hamm, Unna; Mammographie-Einheit Schwerte | Schwerte | North Rhine-Westphalia | 58239 | Germany |
| Screening-Einheit Raum Bergisch Land/Kreis Mettmann; Mammographie-Einheit Solingen-Mitte | Solingen | North Rhine-Westphalia | 42651 | Germany |
| Screening-Einheit Raum Bergisch Land/Kreis Mettmann; Mammographie-Einheit Wuppertal-Elberfeld | Wuppertal | North Rhine-Westphalia | 42109 | Germany |
| Derived |
| Weigel S, Hense HW, Weyer-Elberich V, Gerss J, Heindel W; TOSYMA Screening Trial Group. False-Positive Recall and False-Positive Biopsy Rates in Mammography Screening: A TOSYMA Trial Subanalysis. Radiology. 2025 Sep;316(3):e251014. doi: 10.1148/radiol.251014. |
| 36194110 | Derived | Weigel S, Heindel W, Hense HW, Decker T, Gerss J, Kerschke L; TOSYMA Screening Trial Study Group. Breast Density and Breast Cancer Screening with Digital Breast Tomosynthesis: A TOSYMA Trial Subanalysis. Radiology. 2023 Feb;306(2):e221006. doi: 10.1148/radiol.221006. Epub 2022 Oct 4. |
| 35427470 | Derived | Heindel W, Weigel S, Gerss J, Hense HW, Sommer A, Krischke M, Kerschke L; TOSYMA Screening Trial Study Group. Digital breast tomosynthesis plus synthesised mammography versus digital screening mammography for the detection of invasive breast cancer (TOSYMA): a multicentre, open-label, randomised, controlled, superiority trial. Lancet Oncol. 2022 May;23(5):601-611. doi: 10.1016/S1470-2045(22)00194-2. Epub 2022 Apr 12. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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