Pleural MesotheliomaTIGER MesoNCT05538806
TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study
An observational study of Pleural Mesothelioma, run by NovoCure Ltd. at 23 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Mesothelioma
- What is being tested?
- TTFields
- Type of treatment
- Medical device
- How many people
- 198 participants
- Where
- 23 sitesin 3 countries
- Study dates
- 1 Aug 2023to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult, histologically confirmed pleural mesothelioma without any option of curative resection
Who may be able to join
- ≥ 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
Who cannot join
- Previous treatment with NovoTTF-200T for more than 1 week at day of enrollment
Trial locations and contacts
23 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
23 sites in 3 countries
Germany20 sites, 20 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin, 13353
Nikolaj Frost
- Recruiting
Lungenklinik Heckeshorn
Berlin, 14165
Daniel Misch
- Recruiting
Klinikum Bremen-Ost
Bremen, Free Hanseatic City of Bremen, 28325
André Bethge
- Recruiting
Kliniken der Stadt Koeln
Cologne, 51109
Carolin Gross-Ophoff-Müller
- Recruiting
University Hospital Carl Gustav Carus Dresden
Dresden, Saxony, 01307
Till Ploenes
- Recruiting
Florence-Nightingale-Hospital
Düsseldorf, 40489
Aris Koryllos, +49 211 409-0, thoraxchirurgie@kaiserswerther-diakonie.de
- Recruiting
Klinikum Essen-Mitte
Essen, 45136
Konstantinos Ferrentinos, onkologie@kem-med.com
- Recruiting
University Hospital Essen
Essen, 45147
Martin Metzenmacher
- Recruiting
Lungenklinik Gauting
Gauting, Bavaria, 82131
Rudolf A Hatz
- Recruiting
Niels-Stensen Hospital
Georgsmarienhütte, 49124
- Recruiting
University Medicine Göttingen
Göttingen, Lower Saxony, 37075
Rami El-Shafie, +49 551 3964505, strahlentherapie.leitstelle@med.uni-goettingen.de
- Recruiting
Krankenhaus Martha-Maria Halle-Doelau
Halle, 06120
Wolfgang Schuette
- Recruiting
Medizinische Hochschule Hannover
Hanover, 30625
Heiko Golpon, +49 511 532 6553, Onkologisches.Zentrum@mh-hannover.de
- Recruiting
Asklepios Klinikum Harburg
Harburg, Free and Hanseatic City of Hamburg, 21075
Claas Wesseler
- Recruiting
Lungenklinik Hemer
Hemer, 58675
Karsten Schulmann
- Recruiting
Evangelisches Krankenhaus Herne
Herne, 44623
Daniel Christoph, info@evk-herne.de
- Recruiting
Krankenhaus Bethanien Moers
Moers, 47441
Kato Kambartel
- Recruiting
GEHO Muenster
Münster, 48153
Rüdiger Liersch, geho@onkologie-muenster.de
- Recruiting
University Hospital Regensburg
Regensburg, Bavaria, 93053
Michael Ried
- Recruiting
Fachkliniken Wangen
Wangen, 88239
Philipp Meyn
Italy2 sites, 2 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria di Alessandria "SS. Antonio e Biagio e C. Arrigo"
Alessandria
Federica Grosso
- Recruiting
Humanitas Gavazzeni
Bergamo
Giovanni Luca Ceresoli
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC Cancer Centre
Rotterdam, 3015
Joachim Aerts
About this study
Official title: TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study - TIGER Meso Study
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.
- Conditions
- Pleural Mesothelioma
- Being tested
- TTFields
- Keywords
- Pleural Mesothelioma, TTFields
- Medical subject headings
- Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTFieldsDevice
all patients will receive routine clinical care and TTFields
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | all patients will receive routine clinical care and TTFields Receives: Device: TTFields |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time.
Measured: 54 Months
Secondary outcomes (2)
Number of TTFields treatment-related SAEs, as assessed by the CEC, within total observation period, standardized to average annual incidences.
Measured: 3 years + 18 months follow up
Changes in quality of life comparing baseline with 3 and 6 months after start of TTFields therapy.
Measured: QoL will be assessed at baseline, 3 and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Aug 2023
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovoCure Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538806
- Sponsor's protocol ID
- CIP-RS-001
- Acronym
- TIGER Meso
- Status last verified
- Dec 2024
- First submitted
- 6 Sep 2022
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study - TIGER Meso Study
- ClinicalTrials.gov ID
- NCT05538806
- Acronym / sponsor ID
- TIGER Meso / CIP-RS-001
- Conditions
- Pleural Mesothelioma
- Keywords
- Pleural Mesothelioma, TTFields
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- NovoCure Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: TTFieldsall patients will receive routine clinical care and TTFields |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult, histologically confirmed pleural mesothelioma without any option of curative resection
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (1 listed)
- Previous treatment with NovoTTF-200T for more than 1 week at day of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TTFieldsall patients will receive routine clinical care and TTFields | Device | Group 1 |
Primary outcome
Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time.
Time frame: 54 Months
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
23 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleural Mesothelioma, run by NovoCure Ltd. at 23 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany, Italy, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Ceresoli (+392 9626717, giovanni.ceresoli@mc.humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time. (time frame: 54 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.