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

• Conditions: Malignant Glioma; Glioblastoma

• Registration Number: NCT02047058
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Status Verified: 2014-01
• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-25
• Last Update Submitted: 2014-01-25
• Study First Posted: 2014-01-28
• Last Update Posted: 2014-01-28
• Study Start: 2014-03
• Primary Completion: 2016-12
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effect of each single molecular marker of Q cell on overall survival	3-5 days postoperatively	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.
The effect of each single molecular marker of Q cell on progression-free survival	3-5 days postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
We will correlate molecular markers of Q cell with other genetic alterations	3-5 days postoperatively	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.

Trial Locations

Locations (1)

Nanfang Glioma Centre; 🇨🇳 Guangzhou, Guangdong, China