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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

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chu Amiens Picardie
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AmiensFranceRecruiting
Institut Sainte-Catherine
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AvignonFranceRecruiting
Chu Saint Andre
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BordeauxFranceRecruiting
Chu Brest Hopital Morvan
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BrestFranceRecruiting
Hopital Neurologie Pierre Wetrheimer
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BronFranceRecruiting
Crlcc Francois Baclesse
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CaenFranceRecruiting
Centre Lutte Contre Le Cancer Jean Perrin
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Clermont-FerrandFranceRecruiting
Crlcc Georges Francois Leclerc
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DijonFranceRecruiting
Chu de Grenoble Alpes
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La TroncheFranceRecruiting
Hopital Roger Salengro
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LilleFranceRecruiting
Centre Hospitalier La Timone
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MarseilleFranceRecruiting
Institut du Cancer de Montpellier - Val d'Aurelle
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MontpellierFranceRecruiting
CHU de Nice
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NiceFranceRecruiting
CHU de Nîmes - HOPITAL CAREMEAU
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NîmesFranceRecruiting
Ch Regional Orleans
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OrléansFranceRecruiting
Gh Pitie Salpetriere Aphp
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ParisFranceRecruiting
Hopital Saint Louis
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ParisFranceRecruiting
CRLCC - Centre Eugène Marquis
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RennesFranceRecruiting
Crlcc Henri Becquerel
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RouenFranceRecruiting
Chu de Saint Etienne
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Saint-Priest-en-JarezFranceRecruiting
Hopital Foch
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SuresnesFranceRecruiting
Hia Sainte Anne
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ToulonFranceRecruiting
Institut Claudius Regaud
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ToulouseFranceRecruiting
Institut Gustave Roussy
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VillejuifFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.