Examining gut microbiome effects in glioblastoma patients undergoing treatment

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 observational study aims to assess the feasibility of collecting and analyzing stool samples from adults with newly diagnosed glioblastoma multiforme (GBM) who are undergoing chemoradiation. Participants will provide stool samples at four different time points during their treatment and complete a diet diary and health-related quality of life questionnaires. The study seeks to correlate changes in gut microbiome composition with patient survival outcomes and the occurrence of radiation necrosis. The ultimate goal is to determine if gut microbiome diversity can influence treatment outcomes in GBM patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with newly diagnosed WHO grade 4 glioblastoma, IDH-1 R132H wild type
* Maximum safe resection (≥70% of initial tumor volume resected)
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 or ECOG 2 if on ≤ 8 mg/day of dexamethasone (or bioequivalent)
* Plan to receive 60 Gy / 30 fractions of radiation with temozolomide within 12 weeks of surgery
* Patient or substitute decision maker able to provide written informed consent

Exclusion Criteria:

* Metastatic cancer or secondary cancer that could affect interpretation of primary and secondary study outcomes
* Receiving additional systemic therapy / clinical intervention for glioblastoma that would prevent a uniform treatment cohort with temozolomide and radiation x 6 weeks followed by adjuvant temozolomide 150-200 mg/m2 on days 1-5 every 28 days for up to 6 cycles.\*
* Inability to collect study stool samples
* Any diagnosis or medical condition, physical and / or psychological, that the investigator feels precludes the patient from participation in the study.

  * If there is a new standard of care treatment for newly diagnosed GBM before the first patient is enrolled (e.g., Optune Tumor Treating Fields), then we will allow all patients on this study to adopt the new standard of care therapy. To allow for maximum patient accrual, if patient chooses to enroll on an open label randomized therapeutic study whereby the control arm involves only the standard of care treatment, then patients enrolled in the control arm could be eligible for this study at the discretion of the investigator.

Where it's running

• The Ottawa Hospital Cancer Centre
  Ottawa, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Terry L. Ng, MD
• Email: teng@toh.ca
• Phone: 613-737-7700

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Temozolomide with or without WSD0922-FU for EGFR-Mutant, IDH-Wildtype Glioblastoma

  This trial tests whether adding WSD0922-FU to temozolomide helps slow disease progression in adults with EGFR-mutant, IDH-wildtype glioblastoma.

  Recruiting at 3 sites Phase 2 Mayo Clinic · Scottsdale, Arizona and 2 other locations · NCT07708961

• Retifanlimab With or Without DFMO for Progressive High-Grade Gliomas

  This trial tests whether retifanlimab, with or without DFMO, is safe and may help treat progressive high-grade gliomas in adults.

  Recruiting Phase 1/2 Mayo Clinic · Rochester, Minnesota · NCT07468136

• Temporally-Modulated Pulsed Radiation Therapy plus TMZ for MGMT-Unmethylated Glioblastoma

  This study tests whether temporally-modulated pulsed radiation therapy plus temozolomide improves outcomes for people with newly diagnosed MGMT-unmethylated, IDH-wildtype glioblastoma.

  Recruiting at 54 sites Phase 3 NRG Oncology · Irvine, California and 53 other locations · NCT07452458

• GI-102 With or Without Pembrolizumab Before Surgery for Recurrent or Progressive Grade 4 Gliomas

  The team will test whether giving GI-102 alone or together with pembrolizumab before surgery helps adults with recurrent or progressive IDH‑wildtype glioblastoma or IDH‑mutant grade 4 astrocytoma.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT07301268

• 177Lu-PSMA-617 treatment for IDH‑wildtype gliomas

  This trial will test whether the radiopharmaceutical 177Lu-PSMA-617 is safe for adults with IDH‑wildtype gliomas who have completed standard surgery and radiation.

  Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07223034

• Using a continuous glucose monitor to manage high blood sugar in glioblastoma

  We will try continuous glucose monitors to help adults with newly diagnosed glioblastoma control high blood sugar during treatment.

  Recruiting Mayo Clinic · Phoenix, Arizona and 2 other locations · NCT07091864

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.