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

January 25, 2014 updated by: Nanfang Hospital of Southern Medical University

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

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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Glioma Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with glioblastoma undergo operation and sufficient tumor specimens

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
high-risk
high-risk is determined by the evaluation of the biomarkers of Q cell.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of each single molecular marker of Q cell on progression-free survival
Time Frame: 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.
3-5 days postoperatively
The effect of each single molecular marker of Q cell on overall survival
Time Frame: 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.
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
Time Frame: 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.
3-5 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

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

Investigators

  • Principal Investigator: Songtao Qi, Doctor, Nanfang Glioma centre, Guangzhou, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

March 1, 2017

Study Registration Dates

First Submitted

January 21, 2014

First Submitted That Met QC Criteria

January 25, 2014

First Posted (ESTIMATE)

January 28, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2014

Last Update Submitted That Met QC Criteria

January 25, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFGC-001-MCP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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