Investigating biomarkers in glioblastoma patients treated with TTFields
Study of Biologic Tumor and Plasma Biomarkers of Response to TTFields in Patients Treated for Newly Diagnosed Glioblastoma
This study is testing how well a new treatment called TTFields works for people with newly diagnosed glioblastoma by looking for signs in their blood and tumors that show if they respond to the treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Claudius Regaud Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT06222138 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed glioblastoma who are about to start radio-chemotherapy followed by TTFields.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to TTFields or sampling procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify biomarkers that predict patient response to TTFields, potentially improving treatment outcomes for glioblastoma.
How similar studies have performed: While this approach is focused on biomarker identification in glioblastoma, similar studies have shown promise in understanding treatment responses in other cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Toulouse
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.