Actively Recruiting

Age: 18Years +
All Genders
NCT06924099

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

Led by NovoCure Ltd. · Updated on 2025-04-11

430

Participants Needed

24

Research Sites

263 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant aged 218 years old.
  • Newly diagnosed with glioblastoma (GBM).
  • Completed radiochemotherapy after surgery or biopsy.
  • Within first two cycles of maintenance temozolomide (TMZ).
  • Physician has decided to initiate treatment with Optune4 according to guidelines.
Not Eligible

You will not qualify if you...

  • Currently participating in a clinical trial studying a different treatment.
  • Currently breastfeeding.
  • Pregnant, thinks she might be pregnant, or trying to become pregnant; must use contraception if of childbearing potential.
  • Suffering from significant neurological diseases such as epilepsy, dementia, degenerative disorders, meningitis, encephalitis, or hydrocephalus with increased intracranial pressure.
  • Known sensitivity to conductive hydrogels used with medical electrodes.
  • Has active implanted medical devices, cranial defects, or bullet fragments.
  • Under judicial or administrative deprivation of liberty or legal protection measures (e.g., guardianship).

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 24 locations

1

Chu Amiens Picardie

Amiens, France, 80000

Actively Recruiting

2

Institut Sainte-Catherine

Avignon, France, 84000

Actively Recruiting

3

Chu Saint Andre

Bordeaux, France, 33000

Actively Recruiting

4

Chu Brest Hopital Morvan

Brest, France, 29609

Actively Recruiting

5

Hopital Neurologie Pierre Wetrheimer

Bron, France, 69500

Actively Recruiting

6

Crlcc Francois Baclesse

Caen, France, 14000

Actively Recruiting

7

Centre Lutte Contre Le Cancer Jean Perrin

Clermont-Ferrand, France, 63011

Actively Recruiting

8

Crlcc Georges Francois Leclerc

Dijon, France, 21000

Actively Recruiting

9

Chu de Grenoble Alpes

La Tronche, France, 38700

Actively Recruiting

10

Hopital Roger Salengro

Lille, France, 59000

Actively Recruiting

11

Centre Hospitalier La Timone

Marseille, France, 13000

Actively Recruiting

12

Institut du Cancer de Montpellier - Val d'Aurelle

Montpellier, France, 34298

Actively Recruiting

13

CHU de Nice

Nice, France, 06000

Actively Recruiting

14

CHU de Nîmes - HOPITAL CAREMEAU

Nîmes, France, 30000

Actively Recruiting

15

Ch Regional Orleans

Orléans, France, 45067

Actively Recruiting

16

Hopital Saint Louis

Paris, France, 75010

Actively Recruiting

17

Gh Pitie Salpetriere Aphp

Paris, France

Actively Recruiting

18

CRLCC - Centre Eugène Marquis

Rennes, France, 35000

Actively Recruiting

19

Crlcc Henri Becquerel

Rouen, France, 76000

Actively Recruiting

20

Chu de Saint Etienne

Saint-Priest-en-Jarez, France, 42271

Actively Recruiting

21

Hopital Foch

Suresnes, France, 92151

Actively Recruiting

22

Hia Sainte Anne

Toulon, France, 83000

Actively Recruiting

23

Institut Claudius Regaud

Toulouse, France, 31059

Actively Recruiting

24

Institut Gustave Roussy

Villejuif, France, 94805

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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