NCT06924099Recruiting
TTFields General Routine Clinical Care in ndGBM Patients: a French Prospective Non-Interventional Study (TIGER France)
Tumor Treating Fields General Routine Clinical Care in Newly Diagnosed Glioblastoma Patients: a French Prospective Non-Interventional Study - TIGER France
Source: ClinicalTrials.gov · Last updated 11 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 430 (estimated)
- First submitted
- 18 Sept 2024
- Start date
- 11 Jan 2024
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- NovoCure Ltd.
- Diseases
- Glioblastoma
- NCT number
- NCT06924099
What you commit to
- Study type: Observational
- Planned participants: 430
- From 11 Jan 2024 to the primary completion date, 31 Jan 2029
- 24 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient suffering from a significant neurological disease (primary epilepsy, dementia, progressive degenerative neurological disorder, meningitis or encephalitis, hydrocephalus associated with increased intracranial pressure).
Other
- 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 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Amiens Picardie Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| Institut Sainte-Catherine Coordinator of this site? Confirm its status | Avignon | France | Recruiting |
| Chu Saint Andre Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Chu Brest Hopital Morvan Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Hopital Neurologie Pierre Wetrheimer Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Crlcc Francois Baclesse Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| Centre Lutte Contre Le Cancer Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Crlcc Georges Francois Leclerc Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Chu de Grenoble Alpes Coordinator of this site? Confirm its status | La Tronche | France | Recruiting |
| Hopital Roger Salengro Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Centre Hospitalier La Timone Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Institut du Cancer de Montpellier - Val d'Aurelle Coordinator of this site? Confirm its status | Montpellier | France | Recruiting |
| CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| CHU de Nîmes - HOPITAL CAREMEAU Coordinator of this site? Confirm its status | Nîmes | France | Recruiting |
| Ch Regional Orleans Coordinator of this site? Confirm its status | Orléans | France | Recruiting |
| Gh Pitie Salpetriere Aphp Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| CRLCC - Centre Eugène Marquis Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Crlcc Henri Becquerel Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| Chu de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Recruiting |
| Hopital Foch Coordinator of this site? Confirm its status | Suresnes | France | Recruiting |
| Hia Sainte Anne Coordinator of this site? Confirm its status | Toulon | France | Recruiting |
| Institut Claudius Regaud Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.