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The purpose of this post-authorisation medical device study is to obtain real life data on the use of Tumor Treating Fields (TTFields) in patients with pleural mesothelioma in routine clinical care. Patients with pleural mesothelioma and clinical indication for TTFields treatment will be enrolled in the study after signing Informed consent to use their data and process it centrally for research purposes. The clinical indication for TTFields is one of the inclusion criteria and is defined prior to inclusion by the treating physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | all patients will receive routine clinical care and TTFields |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TTFields | Device | all patients will receive routine clinical care and TTFields |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time. | 54 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of TTFields treatment-related SAEs, as assessed by the CEC, within total observation period, standardized to average annual incidences. | 3 years + 18 months follow up | |
| Changes in quality of life comparing baseline with 3 and 6 months after start of TTFields therapy. |
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Inclusion Criteria:
Exclusion Criteria:
• Previous treatment with NovoTTF-200T for more than 1 week at day of enrollment
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Adult, histologically confirmed pleural mesothelioma without any option of curative resection
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giovanni Ceresoli | Contact | +392 9626717 | giovanni.ceresoli@mc.humanitas.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lungenklinik Gauting | Recruiting | Gauting | Bavaria | 82131 | Germany |
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| QoL will be assessed at baseline, 3 and 6 months. |
| University Hospital Regensburg | Recruiting | Regensburg | Bavaria | 93053 | Germany |
|
| Asklepios Klinikum Harburg | Recruiting | Harburg | Free and Hanseatic City of Hamburg | 21075 | Germany |
|
| Klinikum Bremen-Ost | Recruiting | Bremen | Free Hanseatic City of Bremen | 28325 | Germany |
|
| University Medicine Göttingen | Recruiting | Göttingen | Lower Saxony | 37075 | Germany |
|
| University Hospital Carl Gustav Carus Dresden | Recruiting | Dresden | Saxony | 01307 | Germany |
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| Charité Universitätsmedizin Berlin | Recruiting | Berlin | 13353 | Germany |
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| Lungenklinik Heckeshorn | Recruiting | Berlin | 14165 | Germany |
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| Kliniken der Stadt Koeln | Recruiting | Cologne | 51109 | Germany |
|
| Florence-Nightingale-Hospital | Recruiting | Düsseldorf | 40489 | Germany |
|
| Klinikum Essen-Mitte | Recruiting | Essen | 45136 | Germany |
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| University Hospital Essen | Recruiting | Essen | 45147 | Germany |
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| Niels-Stensen Hospital | Recruiting | Georgsmarienhütte | 49124 | Germany |
| Krankenhaus Martha-Maria Halle-Doelau | Recruiting | Halle | 06120 | Germany |
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| Medizinische Hochschule Hannover | Recruiting | Hanover | 30625 | Germany |
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| Lungenklinik Hemer | Recruiting | Hemer | 58675 | Germany |
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| Evangelisches Krankenhaus Herne | Recruiting | Herne | 44623 | Germany |
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| Krankenhaus Bethanien Moers | Recruiting | Moers | 47441 | Germany |
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| GEHO Muenster | Recruiting | Münster | 48153 | Germany |
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| Fachkliniken Wangen | Recruiting | Wangen | 88239 | Germany |
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| Azienda Ospedaliero-Universitaria di Alessandria "SS. Antonio e Biagio e C. Arrigo" | Recruiting | Alessandria | Italy |
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| Humanitas Gavazzeni | Recruiting | Bergamo | Italy |
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| Erasmus MC Cancer Centre | Recruiting | Rotterdam | 3015 | Netherlands |
|
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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