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

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ClinicalTrials.gov Identifier: NCT05538806
Recruitment Status : Recruiting
First Posted : September 14, 2022
Last Update Posted : April 23, 2024
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd. ( NovoCure GmbH )

Study Description
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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.

Condition or disease Intervention/treatment
Pleural Mesothelioma Device: TTFields

Study Design
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Study Type : Observational
Estimated Enrollment : 198 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study - TIGER Meso Study
Actual Study Start Date : August 1, 2023
Estimated Primary Completion Date : September 30, 2027
Estimated Study Completion Date : March 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time. [ Time Frame: 54 Months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult, histologically confirmed pleural mesothelioma without any option of curative resection
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05538806


Contacts
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Contact: Giovanni Ceresoli +392 9626717 giovanni.ceresoli@mc.humanitas.it

Locations
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Germany
University Hospital Regensburg Recruiting
Regensburg, Bavaria, Germany, 93053
Contact: Michael Ried         
Asklepios Klinikum Harburg Recruiting
Hamburg-Harburg, Hamburg, Germany, 21075
Contact: Claas Wesseler         
University Hospital Carl Gustav Carus Dresden Recruiting
Dresden, Saxony, Germany, 01307
Contact: Till Ploenes         
Lungenklinik Heckeshorn Recruiting
Berlin, Germany, 14165
Contact: Daniel Misch         
Klinikum Bremen-Ost Recruiting
Bremen, Germany, 28325
Contact: André Bethge         
Kliniken der Stadt Koeln Recruiting
Cologne, Germany, 51109
Contact: Carolin Gross-Ophoff-Müller         
Klinikum Essen-Mitte Recruiting
Essen, Germany, 45136
Contact: Daniel Cristoph         
University Hospital Essen Recruiting
Essen, Germany, 45147
Contact: Martin Metzenmacher         
Krankenhaus Martha-Maria Halle-Doelau Recruiting
Halle, Germany, 06120
Contact: Wolfgang Schuette         
Lungenklinik Hemer Recruiting
Hemer, Germany, 58675
Contact: Karsten Schulmann         
Krankenhaus Bethanien Moers Recruiting
Moers, Germany, 47441
Contact: Kato Kambartel         
Fachkliniken Wangen Recruiting
Wangen, Germany, 88239
Contact: Philipp Meyn         
Italy
Azienda Ospedaliero-Universitaria di Alessandria "SS. Antonio e Biagio e C. Arrigo" Recruiting
Alessandria, Italy
Contact: Federica Grosso         
Humanitas Gavazzeni Recruiting
Bergamo, Italy
Contact: Giovanni Luca Ceresoli         
Sponsors and Collaborators
NovoCure GmbH
More Information
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Responsible Party: NovoCure GmbH
ClinicalTrials.gov Identifier: NCT05538806    
Other Study ID Numbers: CIP-RS-001
First Posted: September 14, 2022    Key Record Dates
Last Update Posted: April 23, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by NovoCure Ltd. ( NovoCure GmbH ):
Pleural Mesothelioma
TTFields
Additional relevant MeSH terms:
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Mesothelioma
Mesothelioma, Malignant
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
 Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Pleural Neoplasms
Lung Diseases
Respiratory Tract Diseases