Status:
RECRUITING
TTFields General Routine Clinical Care in ndGBM Patients: a French Prospective Non-Interventional Study (TIGER France)
Lead Sponsor:
NovoCure Ltd.
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Brief Summary
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 t...
Detailed Description
GBM is one of the most common malignant primary brain tumor in adults with an overall incidence in Europe and in France of approximately 3/100,000. In France, 2,233 patients were estimated to be diagn...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 11 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2029
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT06924099
Start Date
January 11 2024
End Date
January 31 2029
Last Update
April 11 2025
Active Locations (24)
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1
Chu Amiens Picardie
Amiens, France, 80000
2
Institut Sainte-Catherine
Avignon, France, 84000
3
Chu Saint Andre
Bordeaux, France, 33000
4
Chu Brest Hopital Morvan
Brest, France, 29609