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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02047058
Enrollment
240
Registered
2014-01-28
Start date
2014-03-31
Completion date
2017-03-31
Last updated
2014-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma, Malignant Glioma

Keywords

biomarker, Q cell, Overall survival, Progression-free survival

Brief summary

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

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.

Interventions

None listed

Sponsors

Guangzhou General Hospital of Guangzhou Military Command
CollaboratorOTHER
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
CollaboratorOTHER
First Affiliated Hospital of Fujian Medical University
CollaboratorOTHER
The First Affiliated Hospital of Nanchang University
CollaboratorOTHER
Capital Medical University
CollaboratorOTHER
Tianjin Medical University General Hospital
CollaboratorOTHER
Shenzhen Second People's Hospital
CollaboratorOTHER
Huashan Hospital
CollaboratorOTHER
West China Hospital
CollaboratorOTHER
Xiangya Hospital of Central South University
CollaboratorOTHER
The First Hospital of Jilin University
CollaboratorOTHER
First Hospital of China Medical University
CollaboratorOTHER
Qilu Hospital of Shandong University
CollaboratorOTHER
Second Affiliated Hospital of Soochow University
CollaboratorOTHER
Sun Yat-sen University
CollaboratorOTHER
Guangzhou First People's Hospital
CollaboratorOTHER
Xi'an Jiaotong University
CollaboratorOTHER
Southern Medical University, China
CollaboratorOTHER
Second Affiliated Hospital of Guangzhou Medical University
CollaboratorOTHER
Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. \>=18 years old 2. Primary Glioblastoma is newly diagnosed and confirmed histologically 3. Patient is expected to be treated with temozolomide and followed up routinely at the study site. 4. Willing to sign the informed consent

Exclusion criteria

1. Currently enrolled in any other clinical study 2. History of any other malignancies 3. Refusal to give consent 4. No available tumor tissue for IDH analysis.

Design outcomes

Primary

MeasureTime frameDescription
The effect of each single molecular marker of Q cell on progression-free survival3-5 days postoperativelyParticipating 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.
The effect of each single molecular marker of Q cell on overall survival3-5 days postoperativelyParticipating 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.

Secondary

MeasureTime frameDescription
We will correlate molecular markers of Q cell with other genetic alterations3-5 days postoperativelyOther 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.

Countries

China

Contacts

Primary ContactSongtao Qi, Doctor
yuleiguisi@gmail.com+8620-61641804
Backup ContactLei Yu, Doctor
battikindy@163.com+8620-61641806

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026