Status:
RECRUITING
Study of Biologic Tumor and Plasma Biomarkers of Response to TTFields in Patients Treated for Newly Diagnosed Glioblastoma
Lead Sponsor:
Institut Claudius Regaud
Collaborating Sponsors:
NovoCure Ltd.
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Age ≥18 years at the time of study entry.
- Patient with newly diagnosed glioblastoma.
- Patient for which a treatment with radio-chemotherapy followed by TTFields has been decided and has not been started.
- Signed written informed consent.
- Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
- Patient affiliated to a Social Health Insurance in France.
Exclusion
- Any condition contraindicated with sampling procedures required by the protocol.
- Any contraindication to the use of the medical device administering TTFields.
- Simultaneous participation in a therapeutic interventional clinical trial.
- Patient pregnant, or breast-feeding.
- Known history of positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- 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
- Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
Key Trial Info
Start Date :
August 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06222138
Start Date
August 27 2024
End Date
May 1 2028
Last Update
June 5 2025
Active Locations (1)
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1
IUCT-O
Toulouse, France