Evaluating the use of Optune Gio® in patients with newly diagnosed Glioblastoma in France

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective multicenter non-interventional study aims to confirm the survival benefit of the Optune Gio® device in patients with newly diagnosed Glioblastoma (GBM) who have completed radiotherapy and concomitant temozolomide (TMZ). The study will measure overall survival (OS) and progression-free survival (PFS), as well as device usage compliance and its impact on quality of life (QoL) in a real-life setting. Participants will be monitored for their daily life experiences and symptom burden, given the aggressive nature of GBM and its associated disabilities.

Why it matters

Who can join: the full rules

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).

Where it's running

• Chu Amiens Picardie
  Amiens, France Recruiting
• Institut Sainte-Catherine
  Avignon, France Recruiting
• Chu Saint Andre
  Bordeaux, France Recruiting
• Chu Brest Hopital Morvan
  Brest, France Recruiting
• Hopital Neurologie Pierre Wetrheimer
  Bron, France Recruiting
• Crlcc Francois Baclesse
  Caen, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.