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Clinical Trials in France / NCT06924099
Recruiting Observational

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

NCT06924099 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-01-11
Last updated
2025-04-11

Condition(s) studied

Glioblastoma

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
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
Centre Lutte Contre Le Cancer Jean Perrin Clermont-Ferrand France Recruiting
Crlcc Georges Francois Leclerc Dijon France Recruiting
Chu de Grenoble Alpes La Tronche France Recruiting
Hopital Roger Salengro Lille France Recruiting
Centre Hospitalier La Timone Marseille France Recruiting
Institut du Cancer de Montpellier - Val d'Aurelle Montpellier France Recruiting
CHU de Nice Nice France Recruiting
CHU de Nîmes - HOPITAL CAREMEAU Nîmes France Recruiting
Ch Regional Orleans Orléans France Recruiting
Hopital Saint Louis Paris France Recruiting
Gh Pitie Salpetriere Aphp Paris France Recruiting
CRLCC - Centre Eugène Marquis Rennes France Recruiting
Crlcc Henri Becquerel Rouen France Recruiting
Chu de Saint Etienne Saint-Priest-en-Jarez France Recruiting
Hopital Foch Suresnes France Recruiting
Hia Sainte Anne Toulon France Recruiting
Institut Claudius Regaud Toulouse France Recruiting
Institut Gustave Roussy Villejuif France Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06924099 on ClinicalTrials.gov ↗ ← All trials in France