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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03698201
Other study ID # CTRIAL-IE (ICORG) 08-13
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 2009
Est. completion date May 2021

Study information

Verified date April 2023
Source Cancer Trials Ireland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 147
Est. completion date May 2021
Est. primary completion date May 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Non-interventional
Translational, observational study

Locations

Country Name City State
Ireland Beaumont Hospital Dublin

Sponsors (2)

Lead Sponsor Collaborator
Cancer Trials Ireland Royal College of Surgeons, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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