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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02047058
• Other study ID #: NFGC-001-MCP
• Status: Not yet recruiting
• Phase: N/A
• First received: January 21, 2014
• Last updated: January 25, 2014
• Start date: March 2014
• Est. completion date: March 2017

Study information

• Verified date: January 2014
• Source: Nanfang Hospital of Southern Medical University
• Contact: Songtao Qi, Doctor
• Phone: +8620-61641804
• Email: yuleiguisi[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glioblastoma
• Malignant Glioma

Locations

Country	Name	City	State
China	Nanfang Glioma Centre	Guangzhou	Guangdong

Sponsors (20)

Lead Sponsor

Collaborator

Nanfang Hospital of Southern Medical University

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

Country where clinical trial is conducted

China, 

References & Publications (3)

Qi ST, Yu L, Lu YT, Ou YH, Li ZY, Wu LX, Yao F. IDH mutations occur frequently in Chinese glioma patients and predict longer survival but not response to concomitant chemoradiotherapy in anaplastic gliomas. Oncol Rep. 2011 Dec;26(6):1479-85. doi: 10.3892/or.2011.1428. Epub 2011 Aug 19. — View Citation

SongTao Q, Lei Y, Si G, YanQing D, HuiXia H, XueLin Z, LanXiao W, Fei Y. IDH mutations predict longer survival and response to temozolomide in secondary glioblastoma. Cancer Sci. 2012 Feb;103(2):269-73. doi: 10.1111/j.1349-7006.2011.02134.x. Epub 2011 Nov 28. — View Citation

Sturm D, Witt H, Hovestadt V, Khuong-Quang DA, Jones DT, Konermann C, Pfaff E, Tönjes M, Sill M, Bender S, Kool M, Zapatka M, Becker N, Zucknick M, Hielscher T, Liu XY, Fontebasso AM, Ryzhova M, Albrecht S, Jacob K, Wolter M, Ebinger M, Schuhmann MU, van Meter T, Frühwald MC, Hauch H, Pekrun A, Radlwimmer B, Niehues T, von Komorowski G, Dürken M, Kulozik AE, Madden J, Donson A, Foreman NK, Drissi R, Fouladi M, Scheurlen W, von Deimling A, Monoranu C, Roggendorf W, Herold-Mende C, Unterberg A, Kramm CM, Felsberg J, Hartmann C, Wiestler B, Wick W, Milde T, Witt O, Lindroth AM, Schwartzentruber J, Faury D, Fleming A, Zakrzewska M, Liberski PP, Zakrzewski K, Hauser P, Garami M, Klekner A, Bognar L, Morrissy S, Cavalli F, Taylor MD, van Sluis P, Koster J, Versteeg R, Volckmann R, Mikkelsen T, Aldape K, Reifenberger G, Collins VP, Majewski J, Korshunov A, Lichter P, Plass C, Jabado N, Pfister SM. Hotspot mutations in H3F3A and IDH1 define distinct epigenetic and biological subgroups of glioblastoma. Cancer Cell. 2012 Oct 16;22(4):425-37. doi: 10.1016/j.ccr.2012.08.024. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ?rst surgery until tumor progression, death, or end of follow-up. Overall survival (OS) will be calculated from the day of ?rst 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	Yes
Primary	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 ?rst surgery until tumor progression, death, or end of follow-up. Overall survival (OS) will be calculated from the day of ?rst 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	Yes
Secondary	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	Yes