TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study

NCT ID: NCT05538806

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

198 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pleural Mesothelioma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

all patients will receive routine clinical care and TTFields

TTFields

Intervention Type DEVICE

all patients will receive routine clinical care and TTFields

Interventions

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TTFields

all patients will receive routine clinical care and TTFields

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NovoCure Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Klinikum Bremen-Ost

Bremen, City state Bremen, Germany

Site Status RECRUITING

Lungenklinik Gauting

Gauting, Bavaria, Germany

Site Status RECRUITING

University Hospital Regensburg

Regensburg, Bavaria, Germany

Site Status RECRUITING

Asklepios Klinikum Harburg

Harburg, City state of Hamburg, Germany

Site Status RECRUITING

University Medicine Göttingen

Göttingen, Lower Saxony, Germany

Site Status RECRUITING

University Hospital Carl Gustav Carus Dresden

Dresden, Saxony, Germany

Site Status RECRUITING

Charité Universitätsmedizin Berlin

Berlin, , Germany

Site Status RECRUITING

Lungenklinik Heckeshorn

Berlin, , Germany

Site Status RECRUITING

Kliniken der Stadt Koeln

Cologne, , Germany

Site Status RECRUITING

Florence-Nightingale-Hospital

Düsseldorf, , Germany

Site Status RECRUITING

Klinikum Essen-Mitte

Essen, , Germany

Site Status RECRUITING

University Hospital Essen

Essen, , Germany

Site Status RECRUITING

Niels-Stensen Hospital

Georgsmarienhütte, , Germany

Site Status RECRUITING

Krankenhaus Martha-Maria Halle-Doelau

Halle, , Germany

Site Status RECRUITING

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status RECRUITING

Lungenklinik Hemer

Hemer, , Germany

Site Status RECRUITING

Evangelisches Krankenhaus Herne

Herne, , Germany

Site Status RECRUITING

Krankenhaus Bethanien Moers

Moers, , Germany

Site Status RECRUITING

GEHO Muenster

Münster, , Germany

Site Status RECRUITING

Fachkliniken Wangen

Wangen, , Germany

Site Status RECRUITING

Azienda Ospedaliero-Universitaria di Alessandria "SS. Antonio e Biagio e C. Arrigo"

Alessandria, , Italy

Site Status RECRUITING

Humanitas Gavazzeni

Bergamo, , Italy

Site Status RECRUITING

Erasmus MC Cancer Centre

Rotterdam, , Netherlands

Site Status RECRUITING

Countries

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Germany Italy Netherlands

Central Contacts

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Giovanni Ceresoli

Role: CONTACT

+392 9626717

Facility Contacts

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Rudolf A Hatz

Role: primary

Michael Ried

Role: primary

André Bethge

Role: primary

Claas Wesseler

Role: primary

Rami El-Shafie

Role: primary

+49 551 3964505

Till Ploenes

Role: primary

Nikolaj Frost

Role: primary

Daniel Misch

Role: primary

Carolin Gross-Ophoff-Müller

Role: primary

Aris Koryllos

Role: primary

+49 211 409-0

Konstantinos Ferrentinos

Role: primary

Martin Metzenmacher

Role: primary

Wolfgang Schuette

Role: primary

Heiko Golpon

Role: primary

+49 511 532 6553

Karsten Schulmann

Role: primary

Daniel Christoph

Role: primary

Kato Kambartel

Role: primary

Rüdiger Liersch

Role: primary

Philipp Meyn

Role: primary

Federica Grosso

Role: primary

Giovanni Luca Ceresoli

Role: primary

Joachim Aerts

Role: primary

Other Identifiers

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CIP-RS-001

Identifier Type: -

Identifier Source: org_study_id

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