Clinical trial NCT05538806: TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study
Official title: TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study - TIGER Meso Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pleural Mesothelioma
Keywords: Pleural Mesothelioma
TTFields
Lead sponsor: NovoCure Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-14
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult, histologically confirmed pleural mesothelioma without any option of curative resection

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time.
timeFrame: 54 Months
Secondary outcomes:
measure: Number of TTFields treatment-related SAEs, as assessed by the CEC, within total observation period, standardized to average annual incidences.
timeFrame: 3 years + 18 months follow up
measure: Changes in quality of life comparing baseline with 3 and 6 months after start of TTFields therapy.
timeFrame: QoL will be assessed at baseline, 3 and 6 months.
Other outcomes:
Locations:
city: Gauting
country: Germany
facility: Lungenklinik Gauting
state: Bavaria
city: Regensburg
country: Germany
facility: University Hospital Regensburg
state: Bavaria
city: Hamburg-Harburg
country: Germany
facility: Asklepios Klinikum Harburg
state: Hamburg
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus Dresden
state: Saxony
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Lungenklinik Heckeshorn
city: Bremen
country: Germany
facility: Klinikum Bremen-Ost
city: Cologne
country: Germany
facility: Kliniken der Stadt Koeln
city: Düsseldorf
country: Germany
facility: Florence-Nightingale-Hospital
city: Essen
country: Germany
facility: Klinikum Essen-Mitte
city: Essen
country: Germany
facility: University Hospital Essen
city: Georgsmarienhütte
country: Germany
facility: Niels-Stensen Hospital
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria Halle-Doelau
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Herne
country: Germany
facility: Evangelisches Krankenhaus Herne
city: Moers
country: Germany
facility: Krankenhaus Bethanien Moers
city: Muenster
country: Germany
facility: GEHO Muenster
city: Wangen
country: Germany
facility: Fachkliniken Wangen
city: Alessandria
country: Italy
facility: Azienda Ospedaliero-Universitaria di Alessandria "SS. Antonio e Biagio e C. Arrigo"
city: Bergamo
country: Italy
facility: Humanitas Gavazzeni
city: Rotterdam
country: Netherlands
facility: Erasmus MC Cancer Centre
Study officials:
References: