Trial Title:
TTFields in General Routine Clinical Care in Patients with Pleural Mesothelioma Study
NCT ID:
NCT05538806
Condition:
Pleural Mesothelioma
Conditions: Official terms:
Mesothelioma
Mesothelioma, Malignant
Conditions: Keywords:
Pleural Mesothelioma
TTFields
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
TTFields
Description:
all patients will receive routine clinical care and TTFields
Arm group label:
Group 1
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.
Criteria for eligibility:
Study pop:
Adult, histologically confirmed pleural mesothelioma without any option of curative
resection
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lungenklinik Gauting
Address:
City:
Gauting
Zip:
82131
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Rudolf A Hatz
Facility:
Name:
University Hospital Regensburg
Address:
City:
Regensburg
Zip:
93053
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Michael Ried
Facility:
Name:
Asklepios Klinikum Harburg
Address:
City:
Hamburg-Harburg
Zip:
21075
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Claas Wesseler
Facility:
Name:
University Hospital Carl Gustav Carus Dresden
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Till Ploenes
Facility:
Name:
Lungenklinik Heckeshorn
Address:
City:
Berlin
Zip:
14165
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Daniel Misch
Facility:
Name:
Klinikum Bremen-Ost
Address:
City:
Bremen
Zip:
28325
Country:
Germany
Status:
Recruiting
Contact:
Last name:
André Bethge
Facility:
Name:
Kliniken der Stadt Koeln
Address:
City:
Cologne
Zip:
51109
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Carolin Gross-Ophoff-Müller
Facility:
Name:
Florence-Nightingale-Hospital
Address:
City:
Düsseldorf
Zip:
40489
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Aris Koryllos
Phone:
+49 211 409-0
Email:
thoraxchirurgie@kaiserswerther-diakonie.de
Facility:
Name:
Klinikum Essen-Mitte
Address:
City:
Essen
Zip:
45136
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Daniel Cristoph
Facility:
Name:
University Hospital Essen
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Martin Metzenmacher
Facility:
Name:
Niels-Stensen Hospital
Address:
City:
Georgsmarienhütte
Zip:
49124
Country:
Germany
Status:
Recruiting
Facility:
Name:
Krankenhaus Martha-Maria Halle-Doelau
Address:
City:
Halle
Zip:
06120
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Wolfgang Schuette
Facility:
Name:
Lungenklinik Hemer
Address:
City:
Hemer
Zip:
58675
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Karsten Schulmann
Facility:
Name:
Krankenhaus Bethanien Moers
Address:
City:
Moers
Zip:
47441
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Kato Kambartel
Facility:
Name:
Fachkliniken Wangen
Address:
City:
Wangen
Zip:
88239
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Philipp Meyn
Facility:
Name:
Azienda Ospedaliero-Universitaria di Alessandria "SS. Antonio e Biagio e C. Arrigo"
Address:
City:
Alessandria
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Federica Grosso
Facility:
Name:
Humanitas Gavazzeni
Address:
City:
Bergamo
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giovanni Luca Ceresoli
Facility:
Name:
Erasmus MC Cancer Centre
Address:
City:
Rotterdam
Zip:
3015
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Joachim Aerts
Start date:
August 1, 2023
Completion date:
March 31, 2028
Lead sponsor:
Agency:
NovoCure Ltd.
Agency class:
Industry
Source:
NovoCure Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05538806
