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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
Sponsor:
Collaborator:
Royal College of Surgeons, Ireland
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Glioma of Brain 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.

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Translational, observational study

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
Translational, observational study




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Cancer Trials Ireland, Innovation House, Glasnevin Dublin 11, Ireland 353 (1) 6677211 info@cancertrials.ie
Contact: Verena Murphy, PhD 353 (1) 6677211 verena.murphy@cancertrials.ie

Locations
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Ireland
Beaumont Hospital Recruiting
Dublin, Ireland, Dublin 9
Contact: Patrick Morris, MD    353 (0) 1 809 3000      
Sponsors and Collaborators
Cancer Trials Ireland
Royal College of Surgeons, Ireland
Investigators
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Principal Investigator: Jochen Prehn Cancer Trials Ireland
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Responsible Party: Cancer Trials Ireland
ClinicalTrials.gov Identifier: NCT03698201    
Other Study ID Numbers: CTRIAL-IE (ICORG) 08-13
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue