Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT05538806
Status:
RECRUITING
Last Update Posted:
2025-08-22
First Post:
2022-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}], 'ancestors': [{'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 198}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2022-09-06', 'studyFirstSubmitQcDate': '2022-09-09', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time.', 'timeFrame': '54 Months'}], 'secondaryOutcomes': [{'measure': 'Number of TTFields treatment-related SAEs, as assessed by the CEC, within total observation period, standardized to average annual incidences.', 'timeFrame': '3 years + 18 months follow up'}, {'measure': 'Changes in quality of life comparing baseline with 3 and 6 months after start of TTFields therapy.', 'timeFrame': 'QoL will be assessed at baseline, 3 and 6 months.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pleural Mesothelioma', 'TTFields'], 'conditions': ['Pleural Mesothelioma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult, histologically confirmed pleural mesothelioma without any option of curative resection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age\n* Histologically confirmed pleural mesothelioma without any option of curative resection\n* Planned treatment with NovoTTF-200T System according to IFU and medical guidelines\n* Life expectancy more than 3 months at day of enrollment\n* Signed informed consent for use and processing of data\n\nExclusion Criteria:\n\n• Previous treatment with NovoTTF-200T for more than 1 week at day of enrollment'}, 'identificationModule': {'nctId': 'NCT05538806', 'acronym': 'TIGER Meso', 'briefTitle': 'TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'NovoCure Ltd.'}, 'officialTitle': 'TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study - TIGER Meso Study', 'orgStudyIdInfo': {'id': 'CIP-RS-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'all patients will receive routine clinical care and TTFields', 'interventionNames': ['Device: TTFields']}], 'interventions': [{'name': 'TTFields', 'type': 'DEVICE', 'description': 'all patients will receive routine clinical care and TTFields', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82131', 'city': 'Gauting', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Rudolf A Hatz', 'role': 'CONTACT'}], 'facility': 'Lungenklinik Gauting', 'geoPoint': {'lat': 48.06919, 'lon': 11.37703}}, {'zip': '93053', 'city': 'Regensburg', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Ried', 'role': 'CONTACT'}], 'facility': 'University Hospital Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '28325', 'city': 'Bremen', 'state': 'City state Bremen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'André Bethge', 'role': 'CONTACT'}], 'facility': 'Klinikum Bremen-Ost', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': '21075', 'city': 'Harburg', 'state': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Claas Wesseler', 'role': 'CONTACT'}], 'facility': 'Asklepios Klinikum Harburg', 'geoPoint': {'lat': 53.46057, 'lon': 9.98388}}, {'zip': '37075', 'city': 'Göttingen', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Rami El-Shafie', 'role': 'CONTACT', 'email': 'strahlentherapie.leitstelle@med.uni-goettingen.de', 'phone': '+49 551 3964505'}], 'facility': 'University Medicine Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Till Ploenes', 'role': 'CONTACT'}], 'facility': 'University Hospital Carl Gustav Carus Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '13353', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Nikolaj Frost', 'role': 'CONTACT'}], 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14165', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Daniel Misch', 'role': 'CONTACT'}], 'facility': 'Lungenklinik Heckeshorn', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '51109', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Carolin Gross-Ophoff-Müller', 'role': 'CONTACT'}], 'facility': 'Kliniken der Stadt Koeln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '40489', 'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Aris Koryllos', 'role': 'CONTACT', 'email': 'thoraxchirurgie@kaiserswerther-diakonie.de', 'phone': '+49 211 409-0'}], 'facility': 'Florence-Nightingale-Hospital', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '45136', 'city': 'Essen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Konstantinos Ferrentinos', 'role': 'CONTACT', 'email': 'onkologie@kem-med.com'}], 'facility': 'Klinikum Essen-Mitte', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '45147', 'city': 'Essen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Metzenmacher', 'role': 'CONTACT'}], 'facility': 'University Hospital Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '49124', 'city': 'Georgsmarienhütte', 'status': 'RECRUITING', 'country': 'Germany', 'facility': 'Niels-Stensen Hospital', 'geoPoint': {'lat': 52.20296, 'lon': 8.0448}}, {'zip': '06120', 'city': 'Halle', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Wolfgang Schuette', 'role': 'CONTACT'}], 'facility': 'Krankenhaus Martha-Maria Halle-Doelau', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '30625', 'city': 'Hanover', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Heiko Golpon', 'role': 'CONTACT', 'email': 'Onkologisches.Zentrum@mh-hannover.de', 'phone': '+49 511 532 6553'}], 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '58675', 'city': 'Hemer', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Karsten Schulmann', 'role': 'CONTACT'}], 'facility': 'Lungenklinik Hemer', 'geoPoint': {'lat': 51.38707, 'lon': 7.77019}}, {'zip': '44623', 'city': 'Herne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Daniel Christoph', 'role': 'CONTACT', 'email': 'info@evk-herne.de'}], 'facility': 'Evangelisches Krankenhaus Herne', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'zip': '47441', 'city': 'Moers', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Kato Kambartel', 'role': 'CONTACT'}], 'facility': 'Krankenhaus Bethanien Moers', 'geoPoint': {'lat': 51.45342, 'lon': 6.6326}}, {'zip': '48153', 'city': 'Münster', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Rüdiger Liersch', 'role': 'CONTACT', 'email': 'geho@onkologie-muenster.de'}], 'facility': 'GEHO Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '88239', 'city': 'Wangen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Philipp Meyn', 'role': 'CONTACT'}], 'facility': 'Fachkliniken Wangen', 'geoPoint': {'lat': 47.6895, 'lon': 9.83247}}, {'city': 'Alessandria', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Federica Grosso', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliero-Universitaria di Alessandria "SS. Antonio e Biagio e C. Arrigo"', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'city': 'Bergamo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Luca Ceresoli', 'role': 'CONTACT'}], 'facility': 'Humanitas Gavazzeni', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '3015', 'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Joachim Aerts', 'role': 'CONTACT'}], 'facility': 'Erasmus MC Cancer Centre', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Giovanni Ceresoli', 'role': 'CONTACT', 'email': 'giovanni.ceresoli@mc.humanitas.it', 'phone': '+392 9626717'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NovoCure Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}