Blood Biomarker Signature in Glioma
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|ClinicalTrials.gov Identifier: NCT03698201|
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : February 26, 2020
|Condition or disease||Intervention/treatment|
|Glioma of Brain||Other: Non-interventional|
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|
|Estimated Enrollment :||130 participants|
|Official Title:||Are Gliomas in Adults Associated With a Unique Identifying Blood Biomarker Signature?|
|Actual Study Start Date :||July 2009|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2027|
Cohort 1 / High grade Glioma
Translational, observational study
Cohort 2 / Low grade Glioma
Translational, observational study
- Identification of protein and miRNA biomarker ignatures [ Time Frame: 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).
- Correlation with disease progression [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03698201
|Contact: Cancer Trials Ireland, Innovation House, Glasnevin Dublin 11, Ireland||353 (1) email@example.com|
|Contact: Verena Murphy, PhD||353 (1) firstname.lastname@example.org|
|Dublin, Ireland, Dublin 9|
|Contact: Patrick Morris, MD 353 (0) 1 809 3000|
|Principal Investigator:||Jochen Prehn||Cancer Trials Ireland|