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| Name | Class |
|---|---|
| GBG Forschungs GmbH | OTHER |
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Sentinel node biopsy is a well established tool for axillary staging in early breast cancer. So far the impact of a preoperative lymph node scintigraphy is unclear. This study aims to clarify whether a preoperative lymphoscintigraphy is of additional benefit in a prospective randomized multicenter study design.
Sentinel node biopsy is a well established tool for axillary staging in early breast cancer. So far the impact of a preoperative lymph node scintigraphy is unclear. Several studies indicate sentinel node biopsy to be a reliable method irrespective of prior lymph node scintigraphy, but data from prospective randomized trials are not available.
Although a preoperative lymph node scintigraphy is not explicitly demanded in current S3 guidelines in Germany its performance is a common practice.
If a preoperative lymphoscintigraphy could be safely omitted, possible benefits are a facilitation of the preoperative workflow as well as cost reduction for health care systems.
This study aims to clarify whether a preoperative lymphoscintigraphy is of additional benefit in a prospective randomized study design. In the two study arms sentinel node biopsy is performed either with or without knowledge of the preoperative lymphoscintigraphy findings. Primary end point is the average number of histologically detected sentinel lymph nodes per patient in both treatment arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (access to lymphoscintigraphy) | No Intervention | Axillary sentinel lymph node biopsy with preoperative access to lymphoscintigraphy findings | |
| B (no access to lymphoscintigraphy) | Experimental | Axillary sentinel lymph node biopsy without preoperative access to lymphoscintigraphy findings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| without preoperative access to lymphoscintigraphy findings | Procedure | axillary sentinel lymph node biopsy without access to lymphoscintigraphy findings |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average number of histologically detected sentinel lymph nodes per patient | Number of resected sentinel lymph nodes is inversely correlated with false negative rate of sentinel lymph node biopsy. Average number of histologically detected sentinel lymph nodes per patient is assessed through pathologic report and serves as surrogate marker for false negative rate of sentinel node biopsy. | Histological report expected within an average of 2 weeks after sentinel lymph node biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with proven metastasis in sentinel lymph nodes | Histological report expected within an average of 2 weeks after sentinel lymph node biopsy | |
| Rate of completion axillary dissection with proven metastasis in sentinel lymph nodes | A completion axillary dissection can be performed in case of proven metastasis in sentinel lymph nodes. A completion axillary dissection ca be performed either right away during sentinel lymph node biopsy or after completion of neoadjuvant chemotherapy. Hence assessment will be performed within 6 months after initial sentinel lymph node biopsy in order to include all patients planned for neoadjuvant chemotherapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherko Kümmel, MD | Kliniken Essen-Mitte | Principal Investigator |
| Thorsten Kühn, MD | Klinikum Esslingen | Study Chair |
| Johannes Holtschmidt, MD | Kliniken Essen-Mitte | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kliniken Essen-Mitte | Essen | North Rhine-Westphalia | 45136 | Germany | ||
| Brustzentrum im Klinikum Ansbach |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31042410 | Result | Kuemmel S, Holtschmidt J, Gerber B, Von der Assen A, Heil J, Thill M, Krug D, Schem C, Denkert C, Lubitz J, Blohmer JU, Reinisch M, Hotzeldt M, Seither F, Nekljudova V, Schwidde I, Uhrhan K, Von Minckwitz G, Rezai M, Mulowski J, Loibl S, Kuehn T. Prospective, Multicenter, Randomized Phase III Trial Evaluating the Impact of Lymphoscintigraphy as Part of Sentinel Node Biopsy in Early Breast Cancer: SenSzi (GBG80) Trial. J Clin Oncol. 2019 Jun 10;37(17):1490-1498. doi: 10.1200/JCO.18.02092. Epub 2019 May 1. | |
| 31465263 |
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| histological report on subsequent completion axillary dissection within 6 months after initial sentinel lymph node biopsy |
| Detection rates of sentinel nodes lymph nodes with preoperative lymphoscintigraphy vs. intraoperative gamma probe and histological detection rates of sentinel lymph nodes with vs. without preoperative access to lymphoscintigraphy | Histological report expected within an average of 2 weeks after sentinel lymph node biopsy |
| Ansbach |
| 91522 |
| Germany |
| Brustzentrum am Hochwaldkrankenhaus Bad Nauheim | Bad Nauheim | 61231 | Germany |
| Kreisklinik Ebersberg, Brustzentrum | Ebersberg | 85560 | Germany |
| Klinik für Frauenheilkunde & Geburtshilfe, Klinikum Esslingen | Esslingen am Neckar | 73730 | Germany |
| Agaplesion Markus Krankenhaus Frankfurt, Brustzentrum | Frankfurt A. M. | 60431 | Germany |
| Franziskus Hospital Harderberg, Brustzentrum Osnabrück | Georgsmarienhütte | 49129 | Germany |
| Asklepios Harzkliniken Goslar, Brustzentrum | Goslar | 38642 | Germany |
| Klinikum Gütersloh, Klinik für Frauenheilkunde und Geburtshilfe | Gütersloh | 33332 | Germany |
| Sankt Elisabeth Krankenhaus Gütersloh, Frauenklinik | Gütersloh | 33332 | Germany |
| Universitätsklinikum Hamburg Eppendorf | Hamburg | 20246 | Germany |
| Kreiskrankenhaus Bergstrasse, Brustzentrum | Heppenheim an der Bergstrasse | 64646 | Germany |
| Universitätsklinikum Schleswig-Holstein, Brustzentrum Kiel | Kiel | 24105 | Germany |
| Universitätsfrauenklinik Magdeburg, Brustzentrum | Magdeburg | 39108 | Germany |
| Evangelisches Krankenhaus Bethesda, Brustzentrum Niederrhein | Mönchengladbach | 41061 | Germany |
| Universitätsfrauenklinik am Klinikum Südstadt Rostock | Rostock | 18059 | Germany |
| DRK Krankenhaus Saarlouis, Brustzentrum | Saarlouis | 66740 | Germany |
| Leopoldina Krankenhaus Schweinfurt, Brustzentrum | Schweinfurt | 97422 | Germany |
| Klinikum St. Elisabeth Straubing, Brustzentrum | Straubing | 94304 | Germany |
| Katharinen Hospital Unna, Brustzentrum | Unna | 59423 | Germany |
| Kliniken Nordoberpfalz, Frauenklinik | Weiden | 92637 | Germany |
| Marien-Hospital Wesel, Brustzentrum | Wesel | 46483 | Germany |
| Brustzentrum Bern, Engerriedspital/Lindenhofspital | Bern | 3012 | Switzerland |
| Result |
| Holtschmidt J, Kuemmel S, Krug D, Breit E, Kuehn T, Reinisch M. Reply to E. Hindie and A.K. Goel et al. J Clin Oncol. 2019 Oct 10;37(29):2705-2707. doi: 10.1200/JCO.19.01860. Epub 2019 Aug 29. No abstract available. |
| 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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