Search / Trial NCT06222138

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

Launched by INSTITUT CLAUDIUS REGAUD · Jan 15, 2024

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

Glioblastoma Biologic Tumor And Plasma Biomarkers Translational Research Tt Fields

ClinConnect Summary

This clinical trial is researching how certain biological markers in tumors and blood can help us understand how patients with newly diagnosed glioblastoma respond to a treatment called TTFields, which is used alongside radio-chemotherapy. The study aims to include 80 patients who have recently been diagnosed with glioblastoma and are ready to start their treatment. Participants will have blood and tumor samples collected at different points during their treatment to help scientists learn more about why some patients respond well to TTFields while others do not.

To be eligible for this study, participants must be at least 18 years old, have a newly diagnosed glioblastoma, and have a treatment plan that includes radio-chemotherapy followed by TTFields. They also need to be willing to provide informed consent and comply with the study's requirements. Throughout the study, patients will be monitored for their overall health and how long the treatment works for them, with follow-ups lasting up to 24 months. This trial is an important step in improving treatment strategies for glioblastoma and helping doctors understand how to better support their patients.

Gender

ALL

Eligibility 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)

About Institut Claudius Regaud

Institut Claudius Regaud is a leading cancer research and treatment center based in Toulouse, France, renowned for its commitment to advancing oncology through innovative clinical trials and multidisciplinary approaches. As a prominent sponsor of clinical research, the institute focuses on developing and evaluating cutting-edge therapies, enhancing patient care, and improving outcomes in cancer treatment. With a strong emphasis on collaboration and scientific excellence, Institut Claudius Regaud brings together a team of expert researchers, oncologists, and healthcare professionals dedicated to translating laboratory discoveries into effective clinical applications, thereby contributing significantly to the global fight against cancer.

Locations

Toulouse, , France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0