Investigating biomarkers in glioblastoma patients treated with TTFields

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial is a prospective study involving 80 patients with newly diagnosed glioblastoma who will receive radio-chemotherapy followed by treatment with TTFields. The study aims to identify resistance mechanisms and biomarkers that indicate sensitivity or resistance to TTFields. Blood samples will be collected at various stages of treatment, and tumor samples will be obtained during surgery for analysis. The Optune® system, which delivers TTFields, will not be under investigation in this study.

Why it matters

Who can join: the full rules

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)

Where it's running

• Iuct-O
  Toulouse, France Recruiting

Study contacts

• Study coordinator: Elizabeth COHEN-JONATHAN MOYAL
• Email: moyal.elizabeth@iuct-oncopole.fr
• Phone: 05 31 15 54 45

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.