Pleural Mesothelioma
Conditions
Keywords
Pleural Mesothelioma, TTFields
Brief summary
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.
Interventions
DEVICETTFields
all patients will receive routine clinical care and TTFields
Sponsors
NovoCure Ltd.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time. | 54 Months |
Secondary
| Measure | 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. | QoL will be assessed at baseline, 3 and 6 months. |
Countries
Germany, Italy, Netherlands
Contacts
Primary ContactGiovanni Ceresoli
Outcome results
None listed