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Blood Biomarker Signature in Glioma

Study Purpose

This is an exploratory, translational and non-interventional clinical study. The aim of this study is to identify a blood biomarker signature for glioma.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03698201
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Cancer Trials Ireland
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jochen Prehn
Principal Investigator Affiliation	Cancer Trials Ireland
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Terminated
Countries	Ireland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma of Brain

Additional Details

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.

Arms & Interventions

Arms

: 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)

: 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

Interventions

Other: - Non-interventional

Translational, observational study

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beaumont Hospital, Dublin, Ireland

Status

Address

Beaumont Hospital

Dublin, , Dublin 9

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