Study of Biologic Tumor and Plasma Biomarkers of Response to TTFields in Patients Treated for Newly Diagnosed Glioblastoma - Trial NCT06222138
Access comprehensive clinical trial information for NCT06222138 through Pure Global AI's free database. This phase not specified trial is sponsored by Institut Claudius Regaud and is currently Not yet recruiting. The study focuses on Glioblastoma. Target enrollment is 80 participants.
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Study Focus
Sponsor & Location
Institut Claudius Regaud
Timeline & Enrollment
N/A
Mar 01, 2024
Oct 01, 2027
Primary Outcome
Overall Survival (OS) defined as the time from inclusion until death from any cause or last follow-up (censored data).,Time to Progression (TTP) defined as the time from inclusion until progression. Patients without progression are censored at last follow-up.
Summary
This trial is a translational, open-label, monocentric prospective study of 80 patients
 aiming to study resistance mechanisms as well as biomarkers of resistance or sensitivity to
 TTFields.
 
 The study will be conducted on a population of patients with newly diagnosed glioblastoma
 treated with radio-chemotherapy followed by TTFields in the context of either routine care or
 a clinical trial.
 
 In this study, the Optune® system (battery operated device which delivers TTFields to the
 brain) will not be under investigation.
 
 For each included patient, blood samples will be collected during baseline visit (before
 initiation of radio-chemotherapy), then before initiation of TTFields and every 3 months
 during TTFields treatment. Additional blood samples will be scheduled at recurrence (if
 applicable).
 
 Moreover, tumor samples (formalin paraffin embedded (FFPE) tumor block and fresh samples)
 will be collected from surgery specimen on primary tumor by the sponsor for analysis. In case
 of recurrence, and if a second surgery is possible, tumor samples will also be collected.
 
 Tumor samples will be collected from biopsies taken in the course of routine practice and
 from surgical specimens collected during surgical procedure. No additional biopsies will be
 performed for the study.
 
 Patients will be followed-up for time to progression and overall survival for a maximum
 duration of 24 months from the TTFields initiation.
 
 MRI performed by patients during the course of the study will be collected by the sponsor for
 additional future research purposes.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06222138
Non-Device Trial