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Study of Biologic Tumor and Plasma Biomarkers of Response to TTFields in Patients Treated for Newly Diagnosed Glioblastoma

RecruitingNAAges 18 Years - anyAllInstitut Claudius Regaud
NCT06222138 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥18 years at the time of study entry. 2. Patient with newly diagnosed glioblastoma. 3. Patient for which a treatment with radio-chemotherapy followed by TTFields has been decided and has not been started. 4. Signed written informed consent. 5. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol 6. Patient affiliated to a Social Health Insurance in France. Exclusion Criteria: 1. Any condition contraindicated with sampling procedures required by the protocol. 2. Any contraindication to the use of the medical device administering TTFields. 3. Simultaneous participation in a therapeutic interventional clinical trial. 4. Patient pregnant, or breast-feeding. 5. Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 6. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure 7. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
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What it tests

  • The samples described below will be collected:
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Where

1 site
IUCT-O
Toulouse, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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