Blood Biomarker Signature in Glioma

Are Gliomas in Adults Associated With a Unique Identifying Blood Biomarker Signature?

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

Study Overview

• Status: Terminated
• Conditions: Glioma of Brain
• Intervention / Treatment: Other: Non-interventional

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.

• Study Type: Observational
• Enrollment (Actual): 147

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, Dublin 9
    • Beaumont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients with suspected newly diagnosed glioma with planned surgical intervention will be eligible.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1 / High grade Glioma; Cohort 1: Histologically confirmed high grade glioma (grade III) or glioblastoma (GBM, astrocytoma grade IV); Planned treatment (RT alone or Chemotherapy alone or a combination of RT/Chemotherapy)	Other: Non-interventional; Translational, observational study
Cohort 2 / Low grade Glioma; Cohort 2: Histologically confirmed low grade (grade II) glioma; Planned treatment eitherexpectant monitoring orRT alone orChemotherapy alone ora combination of RT/Chemotherapy	Other: Non-interventional; Translational, observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of protein and miRNA biomarker ignatures	Identification of protein and miRNA biomarker signatures in serum of glioma patients as assessed by surface-enhanced laser desorption ionization - time of flight (SELDI-TOF), Isobaric tags for relative and absolute quantitation (iTRAQ) and miRNA array technologies. Profiling experiments will be performed on the serum samples; to find unique glioma associated serum biomarkers; to determine if the levels of discovered biomarkers accurately reflect glioma grade.; to investigate if alterations in levels of glioma associated markers predict glioma progression from low grade to high grade Profiling patient's protein and miRNA biomarker signatures will allow association of expression patterns with tumour grade. We will determine if alterations in levels of identified serum biomarkers correlate with disease progression and patient outcome, including tumour response, time to progression (TTP) and overall survival (OS).	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation with disease progression	The secondary objectives are to determine if alterations in levels of identified serum biomarkers correlate with disease progression and patient outcome, including tumour response, time to progression (TTP) and overall survival (OS).	5 years

Collaborators and Investigators

• Sponsor: Cancer Trials Ireland
• Collaborators: Royal College of Surgeons, Ireland
• Investigators: Principal Investigator: Jochen Prehn, Cancer Trials Ireland

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: October 4, 2018
• First Posted (Actual): October 5, 2018

Study Record Updates

• Last Update Posted (Actual): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma
• Other Study ID Numbers: CTRIAL-IE (ICORG) 08-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No