TIGER PRO-Active - Daily Activity, Sleep and Neurocognitive Functioning Study
NCT ID: NCT04717739
Last Updated: 2023-01-10
Study Results
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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UNKNOWN
500 participants
OBSERVATIONAL
2021-12-30
2025-02-01
Brief Summary
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Detailed Description
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Since 2005, despite plenty of clinical phase III trials conducted, Tumor Treating Fields (TTFields) therapy was the first treatment shown to significantly increase median progression-free survival (PFS), OS and one to five year survival rates compared to the previous standard of care. These results led to FDA approval of TTFields for newly diagnosed GBM and were acknowledged since then by several guidelines recommending TTFields for GBM therapy (e.g. NCCN guidelines for CNS cancers V.1.2018, RCC guideline tumörer I hjärna och ryggmärg 2020-01-14 V3.0, DGHO guideline for glioma in adults ICD-10 C71 March 2019). Today, several national committees in Europe already list TTFields as reimbursed treatment (e.g. Austria, Sweden, Germany).
Data with TTFields therapy in real-world setting is limited and therefore further evaluation of different treatment aspects of TTFields therapy in clinical routine are of interest. In particular the QoL-related aspects neurocognitive functioning, daily activity and sleep quality in this patient cohort is of major interest, given the limited life expectancy with this disease.
This non-interventional study aims to investigate change over time in neurocognitive functioning, sleep quality, and activity in daily life as important determinants of QoL in a large cohort of GBM patients in Germany treated with TTFields in routine clinical care using low-threshold, electronic PRO and modern automated tracking data analyses. The gained results will allow even better understanding of TTFields therapy in daily life of GBM patients and consequently, better informing patients about what to expect when starting this therapy, increasing therapy compliance even further in the long-term.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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GBM with indication for TTFields
newly diagnosed GBM with clinical indication for TTFields
TTFields
Tumor Treating Fields (TTFields) help slow down or stop glioblastoma cancer cells from dividing by disrupting dividing mechanism of cancer cells leading to apoptosis. TTFields are low-intensity, intermediate frequency, alternating electric fields delivered continuously through adhesive patches, called transducer arrays, to the area of the brain where the GBM tumor is located. These transducer arrays are applied to the scalp and are connected to the wearable and portable device. TTFields are approved for the treatment of newly diagnosed and recurrent GBM.
Interventions
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TTFields
Tumor Treating Fields (TTFields) help slow down or stop glioblastoma cancer cells from dividing by disrupting dividing mechanism of cancer cells leading to apoptosis. TTFields are low-intensity, intermediate frequency, alternating electric fields delivered continuously through adhesive patches, called transducer arrays, to the area of the brain where the GBM tumor is located. These transducer arrays are applied to the scalp and are connected to the wearable and portable device. TTFields are approved for the treatment of newly diagnosed and recurrent GBM.
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed, histologically confirmed GBM
* Patient after completion of radiochemotherapy but within first 3 cycles of first-line tumor-specific maintenance chemotherapy
* Clinical indication of treatment with NovoTTF-200A System (Optune®) according to IFU and medical guidelines
* Signed informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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NovoCure Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Glas, Prof.
Role: PRINCIPAL_INVESTIGATOR
University hospital Essen, Essen, Germany
Locations
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Universitätsklinikum Aachen
Aachen, , Germany
Klinikum Aschaffenburg-Alzenau
Aschaffenburg, , Germany
Universitätsklinikum Augsburg (AöR)
Augsburg, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Klinikum Chemnitz
Chemnitz, , Germany
Uniklinik Köln
Cologne, , Germany
Kliniken der Stadt Köln GmbH
Cologne, , Germany
Carl-Thiem-Klinikum Cottbus
Cottbus, , Germany
Universitätsklinik Carl Gustav Carus Dresden
Dresden, , Germany
Sana Kliniken Duisburg
Duisburg, , Germany
Universitätsklinikum Düsseldorf HHU
Düsseldorf, , Germany
HELIOS Klinikum Erfurt
Erfurt, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Universitätsklinikum Essen
Essen, , Germany
Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt, , Germany
Universitätsmedizin Greifswald
Greifswald, , Germany
BG Klinikum Bergmannstrost Halle
Halle, , Germany
Onkologische Schwerpunktpraxis Dres. I. Zander und E. von der Heyde
Hanover, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum des Saarlandes
Homburg, , Germany
Universitätsklinikum Jena
Jena, , Germany
Klinikum Kassel
Kassel, , Germany
Universitätsklinikum SH Campus Kiel
Kiel, , Germany
Otto-von-Guericke-Universität Magdeburg
Magdeburg, , Germany
Med. Fakultät Mannheim der Universität Heidelberg
Mannheim, , Germany
Johannes Wesling Klinikum Minden
Minden, , Germany
Kliniken Maria Hilf GmbH
Mönchengladbach, , Germany
Klinikum Nürnberg
Nuremberg, , Germany
Pius-Hospital Oldenburg
Oldenburg, , Germany
Niels-Stensen-Kliniken - Marienhospital Osnabrück
Osnabrück, , Germany
Universitätsmedizin Rostock
Rostock, , Germany
HELIOS Kliniken Schwerin GmbH
Schwerin, , Germany
Johanniter-Krankenhaus Genthin-Stendal GmbH
Stendal, , Germany
Klinikum Stuttgart
Stuttgart, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Paracelsus-Klinik Zwickau
Zwickau, , Germany
Countries
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Central Contacts
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Facility Contacts
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Giles Vince, Prof.
Role: primary
Ehab Shiban, Prof.
Role: primary
Carsten Schoof, Dr.
Role: primary
Dietmar Krex, Prof.
Role: primary
Rüdiger Gerlach, Prof.
Role: primary
Rainer Fietkau, Prof.
Role: primary
Sied Kebir, Dr.
Role: primary
Anja Glien, Dr.
Role: primary
Eyck von der Heyde, Dr.
Role: primary
Hajrullah Ahmeti, Dr.
Role: primary
Ursula Nestle, Prof.
Role: primary
Gunnar Lohm, Dr.
Role: primary
Daniel Sachs, Dr.
Role: primary
References
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Other Identifiers
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27.09.2021
Identifier Type: -
Identifier Source: org_study_id
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