Treatment Response and Prognosis in Glioma Patients: Q Cell and Its Biological Characteristics

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Q cells separated from the glioma sample are determinants in treatment response and prognosis of glioma patients

Detailed Description
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The unique markers of Qcell were screened using the method of genomics and proteomics, then these markers will be qualitatively and quantitatively evaluated in glioblastoma patients by comparing their relationship with overrall survival/progression-free survival and treatment response.

Official Title
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A Multi-center, Prospective, Observational Study of Analysis of Q Cell Markers in Patients With Newly Diagnosed Primary Glioblastoma (Phase IV)

Conditions
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Glioblastoma, Malignant Glioma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >=18 years old Primary Glioblastoma is newly diagnosed and confirmed histologically Patient is expected to be treated with temozolomide and followed up routinely at the study site. Willing to sign the informed consent Exclusion Criteria: Currently enrolled in any other clinical study History of any other malignancies Refusal to give consent No available tumor tissue for IDH analysis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| high-risk<br>high-risk is determined by the evaluation of the biomarkers of Q cell. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of each single molecular marker of Q cell on progression-free survival | Participating centres collected data and submitted it by Email to the coordinating centre at the Nanfang Glioma Center. 300 patients with glioblastoma will be prospectively enrolled in this study. The unique markers of Q cell which had been screened using the method of genomics and proteomics will be measured and compared with progression-free and overall survival of patients. Regrettably,the markers of Q cell cannot yet be disclosed because of the confidentiality requirement. Progression-free survival (PFS) will be calculated from the day of ﬁrst surgery until tumor progression, death, or end of follow-up. Overall survival (OS) will be calculated from the day of ﬁrst surgery until death or end of follow-up. The effect of each single molecular marker on PFS and OS was investigated using the Cox proportional hazards model. | 3-5 days postoperatively | 
| The effect of each single molecular marker of Q cell on overall survival | Participating centres collected data and submitted it by Email to the coordinating centre at the Nanfang Glioma Center. 300 patients with glioblastoma will be prospectively enrolled in this study. The unique markers of Q cell which had been screened using the method of genomics and proteomics will be measured and compared with progression-free and overall survival of patients. Regrettably,the markers of Q cell cannot yet be disclosed because of the confidentiality requirement. Progression-free survival (PFS) will be calculated from the day of ﬁrst surgery until tumor progression, death, or end of follow-up. Overall survival (OS) will be calculated from the day of ﬁrst surgery until death or end of follow-up. The effect of each single molecular marker on PFS and OS was investigated using the Cox proportional hazards model. | 3-5 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We will correlate molecular markers of Q cell with other genetic alterations | Other genetic alterations which have been previously reported include isocitrate dehydrogenase mutation, o6-methylguanine-DNA-methyltransferase methylation, 1p19q co-delation, Tumor Protein 53 (TP53) mutation, histone H3.3 (H3F3A) mutations, etc. The Chi-square test will be used to compare the genotype distribution. | 3-5 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomarker, Q cell, Overall survival, Progression-free survival