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TTFields General Routine Clinical Care in ndGBM Patients: a French Prospective Non-Interventional Study (TIGER France)

Recruitingn/aAges 18 Years - anyAllNovoCure Ltd.
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In plain words

What the trial is, and whether it could suit you

This prospective multicenter non-interventional study (NIS) aims at confirming the survival benefit of Optune Gio® - in terms of OS and PFS - and describing device usage (compliance will be measured through patient's usage report, recorded by each device) and impact on QoL, in a real-life setting in France, in a large cohort of participants with newly diagnosed GBM who completed radiotherapy and concomitant TMZ after surgery and initiatingtreatment with Optune Gio® device together with maintenance TMZ. A special emphasis will be given to the evaluation of QoL and the impact of Optune Gio® on daily life, considering the limited life expectancy of these patients, the symptom burden and significant disease-related disability.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Participant aged ≥ 18 years old. * Participant with newly diagnosed GBM. * Participant who completed radiochemotherapy after surgery or biopsy. * Participant within first 2 cycles of maintenance TMZ. * Participant for whom the physician has decided to initiate treatment with Optune® according to Instruction For Use or medical guidelines. Exclusion Criteria: * Participant currently participating in a prospective clinical trial studying a different treatment than the one studied in this current prospective study. * Patient currently breastfeeding. * Patient who is pregnant, thinks she might be pregnant or is trying to become pregnant. Patient of childbearing potential must use a contraceptive method for the whole duration of their participation in the study. * Patient suffering from a significant neurological disease (primary epilepsy, dementia, progressive degenerative neurological disorder, meningitis or encephalitis, hydrocephalus associated with increased intracranial pressure). * Patient with a known sensitivity to conductive hydrogels, such as gel used with electrocardiogram (ECG) or transcutaneous electrical nerve stimulation (TENS) electrodes. * Patient with an active implanted medical device, a cranial defect (such as a missing bone that has not been replaced) or bullet fragments. Active electronic devices include, for example, deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers and defibrillators. * Participant being deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection (e.g. guardianship or curatorship).
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What it tests

  • Not listed
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Where

24 sites
Chu Amiens Picardie
Amiens, France
Institut Sainte-Catherine
Avignon, France
Chu Saint Andre
Bordeaux, France
Chu Brest Hopital Morvan
Brest, France
Hopital Neurologie Pierre Wetrheimer
Bron, France
Crlcc Francois Baclesse
Caen, France
Centre Lutte Contre Le Cancer Jean Perrin
Clermont-Ferrand, France
Crlcc Georges Francois Leclerc
Dijon, France

…and 16 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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