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

Обзор

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.

Вмешательства

• Другое The samples described below will be collected:
  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 surge

Первичные конечные точки

• Overall Survival (OS) defined as the time from inclusion until death from any cause or last follow-up (censored data). [Срок оценки: 27 months for each patient]
• Time to Progression (TTP) defined as the time from inclusion until progression. Patients without progression are censored at last follow-up. [Срок оценки: 27 months for each patient]

Вторичные конечные точки (1)

• Number of patients with MRI collected. [Срок оценки: 27 months for each patient]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• IUCT-O — Toulouse

Идентификаторы

NCT: NCT06222138 · 23 TETE 04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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