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.
Study Type
OBSERVATIONAL
Enrollment
198
all patients will receive routine clinical care and TTFields
Lungenklinik Gauting
Gauting, Bavaria, Germany
RECRUITINGUniversity Hospital Regensburg
Regensburg, Bavaria, Germany
RECRUITINGAsklepios Klinikum Harburg
Harburg, Free and Hanseatic City of Hamburg, Germany
RECRUITINGKlinikum Bremen-Ost
Bremen, Free Hanseatic City of Bremen, Germany
RECRUITINGUniversity Medicine Göttingen
Göttingen, Lower Saxony, Germany
RECRUITINGUniversity Hospital Carl Gustav Carus Dresden
Dresden, Saxony, Germany
RECRUITINGCharité Universitätsmedizin Berlin
Berlin, Germany
RECRUITINGLungenklinik Heckeshorn
Berlin, Germany
RECRUITINGKliniken der Stadt Koeln
Cologne, Germany
RECRUITINGFlorence-Nightingale-Hospital
Düsseldorf, Germany
RECRUITING...and 13 more locations
Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time.
Time frame: 54 Months
Number of TTFields treatment-related SAEs, as assessed by the CEC, within total observation period, standardized to average annual incidences.
Time frame: 3 years + 18 months follow up
Changes in quality of life comparing baseline with 3 and 6 months after start of TTFields therapy.
Time frame: QoL will be assessed at baseline, 3 and 6 months.
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