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

August 18, 2025 updated by: NovoCure Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Charité Universitätsmedizin Berlin
        • Contact:
          • Nikolaj Frost
      • Berlin, Germany, 14165
        • Recruiting
        • Lungenklinik Heckeshorn
        • Contact:
          • Daniel Misch
      • Bremen, Germany, 28325
        • Recruiting
        • Klinikum Bremen-Ost
        • Contact:
          • André Bethge
      • Cologne, Germany, 51109
        • Recruiting
        • Kliniken der Stadt Koeln
        • Contact:
          • Carolin Gross-Ophoff-Müller
      • Düsseldorf, Germany, 40489
      • Essen, Germany, 45147
        • Recruiting
        • University Hospital Essen
        • Contact:
          • Martin Metzenmacher
      • Essen, Germany, 45136
      • Georgsmarienhütte, Germany, 49124
        • Recruiting
        • Niels-Stensen Hospital
      • Halle, Germany, 06120
        • Recruiting
        • Krankenhaus Martha-Maria Halle-Doelau
        • Contact:
          • Wolfgang Schuette
      • Hannover, Germany, 30625
      • Hemer, Germany, 58675
        • Recruiting
        • Lungenklinik Hemer
        • Contact:
          • Karsten Schulmann
      • Herne, Germany, 44623
        • Recruiting
        • Evangelisches Krankenhaus Herne
        • Contact:
      • Moers, Germany, 47441
        • Recruiting
        • Krankenhaus Bethanien Moers
        • Contact:
          • Kato Kambartel
      • Muenster, Germany, 48153
      • Wangen, Germany, 88239
        • Recruiting
        • Fachkliniken Wangen
        • Contact:
          • Philipp Meyn
    • Bavaria
      • Gauting, Bavaria, Germany, 82131
        • Recruiting
        • Lungenklinik Gauting
        • Contact:
          • Rudolf A Hatz
      • Regensburg, Bavaria, Germany, 93053
        • Recruiting
        • University Hospital Regensburg
        • Contact:
          • Michael Ried
    • Hamburg
      • Hamburg-Harburg, Hamburg, Germany, 21075
        • Recruiting
        • Asklepios Klinikum Harburg
        • Contact:
          • Claas Wesseler
    • Lower Saxony
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • University Hospital Carl Gustav Carus Dresden
        • Contact:
          • Till Ploenes
  • Italy
      • Alessandria, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Alessandria "SS. Antonio e Biagio e C. Arrigo"
        • Contact:
          • Federica Grosso
      • Bergamo, Italy
        • Recruiting
        • Humanitas Gavazzeni
        • Contact:
          • Giovanni Luca Ceresoli
  • Netherlands
      • Rotterdam, Netherlands, 3015
        • Recruiting
        • Erasmus MC Cancer Centre
        • Contact:
          • Joachim Aerts

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult, histologically confirmed pleural mesothelioma without any option of curative resection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
all patients will receive routine clinical care and TTFields
Device: TTFields
all patients will receive routine clinical care and TTFields

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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.
QoL will be assessed at baseline, 3 and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NovoCure Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

September 6, 2022

First Submitted That Met QC Criteria

September 9, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-RS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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