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TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study (TIGER Meso)

Published: September 16, 2022

Primary Outcome Measures

  1. Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time. [ Time Frame: 54 Months ]

Secondary Outcome Measures

  1. 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 ]
  2. 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. ]

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

  • Any foreseeable deviation from the IFU of NovoTTF-200T Device
  • Previous treatment with NovoTTF-200T for more than 1 week at day of enrollment
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