Actively Recruiting

Age: 18Years +
All Genders
NCT06546631

Investigating Mechanistic Predictors of Interpatient Variability and Temozolomide (TMZ) Induced Haematological Toxicity for Glioma Patients

Led by University College Cork · Updated on 2026-03-04

55

Participants Needed

1

Research Sites

170 weeks

Total Duration

On this page

Sponsors

U

University College Cork

Lead Sponsor

U

University Hospital Waterford

Collaborating Sponsor

AI-Summary

What this Trial Is About

A medication called temozolomide has been used for many years in the treatment of high-grade gliomas, which are tumours that originate in the brain. While this drug is the normal treatment for high-grade glioma, a number of patients develop a side-effect which results in low levels of some important blood cells, such as platelets or white blood cells. If this side-effect occurs, treatment with temozolomide may have to be stopped or paused, which may affect how well this treatment works. At present, it is unknown why some patients develop this side effect and others do not. It is known that patients with a higher concentration of temozolomide in their blood are at an increased risk of developing this toxicity. There may be some factors associated with the movement of the drug in the body or the removal of the drug from the body which may affect the concentration of temozolomide in blood. There are many factors which may be involved, including genes, other medicines that are taken, how well kidneys and liver are working or even the microbiome (which is the bacteria in the gut). This study is being done to find out what these factors could be. In the future, this may lead to medical care teams being able to predict which patients are at higher risk of side-effects, allowing them to implement measures to reduce the risk of this occurring.

CONDITIONS

Official Title

Investigating Mechanistic Predictors of Interpatient Variability and Temozolomide (TMZ) Induced Haematological Toxicity for Glioma Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or over
  • Receiving or scheduled to receive concurrent phase temozolomide treatment for high grade glioma (WHO Grade 3 or Grade 4 Astrocytoma, Oligodendroglioma, or Glioblastoma)
  • Provide informed consent to participate
  • Developed any Grade 3 or higher haematological toxicity associated with temozolomide, or specific blood count abnormalities or treatment modifications due to toxicity
  • Provide informed consent to participate
Not Eligible

You will not qualify if you...

  • Clinically too unwell to provide informed consent
  • Additional blood or research samples would not be appropriate or indicated in the opinion of the supervising clinician

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cork University Hospital

Cork, Ireland

Actively Recruiting

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Research Team

J

Jack Gleeson

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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