Blood Biomarker Signature in Glioma

NCT03698201 | Terminated

• 1 other identifier: CTRIAL-IE (ICORG) 08-13
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma of Brain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation with disease progression

  5 years

Study Arms (2)

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)

Other: Non-interventional

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

Other: Non-interventional

Interventions

Non-interventional OTHER

Translational, observational study

Cohort 1 / High grade Glioma; Cohort 2 / Low grade Glioma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All patients with suspected newly diagnosed glioma (grade 2 or 3 or glioblastoma) with planned surgical intervention (resection or biopsy).
• Patient aged 18 years or older
• Patients have to be able to give informed consent

You may not qualify if:

• Prior Radiotherapy to the central nervous system
• Prior Chemotherapy within the last 5 years
• Any prior central nervous system malignancy

Sponsors & Collaborators

• Cancer Trials Ireland: lead
• Royal College of Surgeons, Ireland: collaborator

Study Sites (1)

Beaumont Hospital

Dublin, Dublin 9, Ireland

Location

Study Officials

• Jochen Prehn

  Cancer Trials Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: October 5, 2018
• Study Start: July 1, 2009
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)