Blood Biomarker Signature in Glioma

Terminated

• Conditions: Glioma of Brain
• Interventions: Other: Non-interventional

• Registration Number: NCT03698201
• Lead Sponsor: Cancer Trials Ireland

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-10-04
• Study First Posted: 2018-10-05
• Primary Completion: 2021-05
• Study Completion: 2021-05
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 147

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1 / High grade Glioma	Non-interventional	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)
Cohort 2 / Low grade Glioma	Non-interventional	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

Primary Outcome Measures

Name	Time	Method
Identification of protein and miRNA biomarker ignatures	5 years	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).

Secondary Outcome Measures

Name	Time	Method
Correlation with disease progression	5 years	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).

Trial Locations

Locations (1)

Beaumont Hospital; 🇮🇪 Dublin, Ireland