Pleural Mesothelioma Clinical Trial
— TIGER MesoOfficial title:
TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study - TIGER Meso Study
| NCT number | NCT05538806 |
| Other study ID # | CIP-RS-001 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 1, 2023 |
| Est. completion date | March 31, 2028 |
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.
| Status | Recruiting |
| Enrollment | 198 |
| Est. completion date | March 31, 2028 |
| Est. primary completion date | September 30, 2027 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - = 18 years of age - Histologically confirmed pleural mesothelioma without any option of curative resection - Planned treatment with NovoTTF-200T System according to IFU and medical guidelines - Life expectancy more than 3 months at day of enrollment - Signed informed consent for use and processing of data Exclusion Criteria: • Previous treatment with NovoTTF-200T for more than 1 week at day of enrollment |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Lungenklinik Heckeshorn | Berlin | |
| Germany | Klinikum Bremen-Ost | Bremen | |
| Germany | Kliniken der Stadt Koeln | Cologne | |
| Germany | University Hospital Carl Gustav Carus Dresden | Dresden | Saxony |
| Germany | Klinikum Essen-Mitte | Essen | |
| Germany | University Hospital Essen | Essen | |
| Germany | Krankenhaus Martha-Maria Halle-Doelau | Halle | |
| Germany | Asklepios Klinikum Harburg | Hamburg-Harburg | Hamburg |
| Germany | Lungenklinik Hemer | Hemer | |
| Germany | Krankenhaus Bethanien Moers | Moers | |
| Germany | University Hospital Regensburg | Regensburg | Bavaria |
| Germany | Fachkliniken Wangen | Wangen | |
| Italy | Azienda Ospedaliero-Universitaria di Alessandria "SS. Antonio e Biagio e C. Arrigo" | Alessandria | |
| Italy | Humanitas Gavazzeni | Bergamo |
| Lead Sponsor | Collaborator |
|---|---|
| NovoCure GmbH |
Germany, Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time. | 54 Months | ||
| Secondary | 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 | ||
| Secondary | Changes in quality of life comparing baseline with 3 and 6 months after start of TTFields therapy. | QoL will be assessed at baseline, 3 and 6 months. |
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|---|---|---|---|
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