Blood Biomarker Signature in Glioma

NCT ID: NCT03698201

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 147 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2021-05-31

Brief Summary

This is an exploratory, translational and non-interventional clinical study. The aim of this study is to identify a blood biomarker signature for glioma.

Detailed Description

The identification of biomarkers (proteins, peptides and micro RNAs (miRNAs)) in the serum of patients with glioma would be a new, less invasive approach, which could help in the diagnosis of a glioma, and potentially help guide therapeutic decisions.

The investigators will investigate the existence of biomarker profiles, which can

• distinguish between low and high grade gliomas
• correlate with patient outcomes including response to treatment and survival
• indicate progression from a low to a high grade glioma.

In this study the investigators collect and analyse blood samples taken from patients with suspected newly diagnosed grade II/III glioma or glioblastoma multiforme (GBM). Blood samples will be collected before any surgical intervention (resection or biopsy) and at various follow-up time points until progression or death. Based on the known natural history of gliomas (described above), it is planned to follow patients with grade III/IV tumours, who receive treatment, for up to 3 years and those with grade II-III tumours, (irrespective of treatment) for up to 5 years. Ultimately, the investigators envisage the translation of our observations into the hospital setting to aid the distinction between glioma grade II and grade III/IV.

Conditions

Glioma of Brain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1 / High grade Glioma

Cohort 1:

1. Histologically confirmed high grade glioma (grade III) or glioblastoma (GBM, astrocytoma grade IV)

2. Planned treatment (RT alone or Chemotherapy alone or a combination of RT/Chemotherapy)

Non-interventional

Intervention Type: OTHER

Translational, observational study

Cohort 2 / Low grade Glioma

Cohort 2:

1. Histologically confirmed low grade (grade II) glioma

2. Planned treatment either

• expectant monitoring or
• RT alone or
• Chemotherapy alone or
• a combination of RT/Chemotherapy

Non-interventional

Intervention Type: OTHER

Translational, observational study

Interventions

Non-interventional

Translational, observational study

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. All patients with suspected newly diagnosed glioma (grade 2 or 3 or glioblastoma) with planned surgical intervention (resection or biopsy).

2. Patient aged 18 years or older

3. Patients have to be able to give informed consent

Exclusion Criteria

1. Prior Radiotherapy to the central nervous system

2. Prior Chemotherapy within the last 5 years

3. Any prior central nervous system malignancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal College of Surgeons, Ireland

OTHER

Sponsor Role: collaborator

Cancer Trials Ireland

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jochen Prehn

Role: PRINCIPAL_INVESTIGATOR

Cancer Trials Ireland

Locations

Beaumont Hospital

Dublin, , Ireland

Countries

Ireland

Other Identifiers

CTRIAL-IE (ICORG) 08-13

Identifier Type: -

Identifier Source: org_study_id