Blood Biomarker Signature in Glioma

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 12, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

July 2009

Estimated Primary Completion Date

July 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Biomarkers[ 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).

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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).

Descriptive Information

Brief Title ^ICMJE

Blood Biomarker Signature in Glioma

Official Title ^ICMJE

Are Gliomas in Adults Associated With a Unique Identifying Blood Biomarker Signature?

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. We 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 we 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, we envisage the translation of our observations into the hospital setting to aid the distinction between glioma grade II and grade III/IV.

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Other: Non-interventional
Translational, observational study

Study Arms

: Cohort 1
Cohort 1: Histologically confirmed high grade glioma (grade III) or glioblastoma (GBM, astrocytoma grade IV) Planned treatment (RT alone or Chemotherapy alone or a combination of RT/Chemotherapy)
: Cohort 2
Cohort 2: Histologically confirmed low grade (grade II) glioma Planned treatment either expectant monitoring or RT alone or Chemotherapy alone or a combination of RT/Chemotherapy

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

130

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

July 2027

Estimated Primary Completion Date

July 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Ireland

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Cancer Trials Ireland

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Cancer Ireland, Glasnevin Dublin 11, Ireland Cancer Trials Ireland

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名