Informations générales (source: ClinicalTrials.gov)

NCT06924099 En recrutement IDF
Tumor Treating Fields General Routine Clinical Care in Newly Diagnosed Glioblastoma Patients: a French Prospective Non-Interventional Study - TIGER France (TIGER France)
Observational
  • Glioblastome
NovoCure Ltd. (Voir sur ClinicalTrials)
janvier 2024
janvier 2029
12 avril 2025
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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Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital La Pitié-Salpêtrière GH PITIE SALPETRIERE En recrutement IDF Contact (sur clinicalTrials)
CLCC INSTITUT GUSTAVE ROUSSY inst INSTITUT GUSTAVE ROUSSY En recrutement IDF Contact (sur clinicalTrials)
HOPITAL FOCH Hop HOPITAL FOCH En recrutement IDF Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Hospitalier La Timone - 13000 - Marseille - France CH LA TIMONE En recrutement Contact (sur clinicalTrials)
Centre Lutte Contre Le Cancer Jean Perrin - 63011 - Clermont-Ferrand - France CRLCC CENTRE LUTTE CONTRE LE CANCER JEAN PERRIN En recrutement Contact (sur clinicalTrials)
Ch Regional Orleans - 45067 - Orléans - France CHR CH REGIONAL ORLEANS En recrutement Contact (sur clinicalTrials)
Chu Amiens Picardie - 80000 - Amiens - France CHU AMIENS PICARDIE En recrutement Contact (sur clinicalTrials)
Chu Brest Hopital Morvan - 29609 - Brest - France CHU BREST HOPITAL MORVAN En recrutement Contact (sur clinicalTrials)
Chu de Grenoble Alpes - 38700 - La Tronche - France chu CHU DE GRENOBLE ALPES En recrutement Contact (sur clinicalTrials)
CHU de Nice - 06000 - Nice - France CHU CHU de Nice En recrutement Contact (sur clinicalTrials)
CHU de Nîmes - HOPITAL CAREMEAU - 30000 - Nîmes - France CHU CHU de Nîmes - HOPITAL CAREMEAU En recrutement Contact (sur clinicalTrials)
Chu de Saint Etienne - 42271 - Saint-Priest-en-Jarez - France CHU CHU DE SAINT ETIENNE En recrutement Contact (sur clinicalTrials)
Chu Saint Andre - 33000 - Bordeaux - France CHU SAINT ANDRE En recrutement Contact (sur clinicalTrials)
CRLCC - Centre Eugène Marquis - 35000 - Rennes - France CRLCC Centre Eugène Marquis En recrutement Contact (sur clinicalTrials)
Crlcc Francois Baclesse - 14000 - Caen - France CRLCC FRANCOIS BACLESSE En recrutement Contact (sur clinicalTrials)
Crlcc Georges Francois Leclerc - 21000 - Dijon - France CRLCC GEORGES FRANCOIS LECLERC En recrutement Contact (sur clinicalTrials)
Crlcc Henri Becquerel - 76000 - Rouen - France CRLCC HENRI BECQUEREL En recrutement Contact (sur clinicalTrials)
Hia Sainte Anne - 83000 - Toulon - France hia HIA SAINTE ANNE En recrutement Contact (sur clinicalTrials)
Hopital Neurologie Pierre Wetrheimer - 69500 - Bron - France Hop HOPITAL NEUROLOGIE PIERRE WETRHEIMER En recrutement Contact (sur clinicalTrials)
Hopital Roger Salengro - 59000 - Lille - France HOPITAL ROGER SALENGRO En recrutement Contact (sur clinicalTrials)
Hopital Saint Louis - 75010 - Paris - France HOPITAL SAINT LOUIS En recrutement Contact (sur clinicalTrials)
Institut Claudius Regaud - 31059 - Toulouse - France inst INSTITUT CLAUDIUS REGAUD En recrutement Contact (sur clinicalTrials)
Institut du Cancer de Montpellier - Val d'Aurelle - 34298 - Montpellier - France inst Institut du Cancer de Montpellier - Val d'Aurelle En recrutement Contact (sur clinicalTrials)
Institut Sainte-Catherine - 84000 - Avignon - France inst INSTITUT SAINTE-CATHERINE En recrutement Contact (sur clinicalTrials)

Critères

Tous
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.


- 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).