Clinical trial NCT02047058: Treatment Response and Prognosis in Glioma Patients: Q Cell and Its Biological Characteristics
Official title: A Multi-center, Prospective, Observational Study of Analysis of Q Cell Markers in Patients With Newly Diagnosed Primary Glioblastoma (Phase IV)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioblastoma
Malignant Glioma
Keywords: biomarker
Q cell
Overall survival
Progression-free survival
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Guangzhou General Hospital of Guangzhou Military Command
name: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: First Affiliated Hospital of Fujian Medical University
name: The First Affiliated Hospital of Nanchang University
name: Capital Medical University
name: Tianjin Medical University General Hospital
name: Shenzhen Second People's Hospital
name: Huashan Hospital
name: West China Hospital
name: Xiangya Hospital of Central South University
name: The First Hospital of Jilin University
name: First Hospital of China Medical University
name: Qilu Hospital of Shandong University
name: Second Affiliated Hospital of Soochow University
name: Sun Yat-sen University
name: Guangzhou First People's Hospital
name: Xi'an Jiaotong University
name: Southern Medical University, China
name: Second Affiliated Hospital of Guangzhou Medical University
First posted: 2014-01-28
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with glioblastoma undergo operation and sufficient tumor specimens

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The effect of each single molecular marker of Q cell on progression-free survival
timeFrame: 3-5 days postoperatively
measure: The effect of each single molecular marker of Q cell on overall survival
timeFrame: 3-5 days postoperatively
Secondary outcomes:
measure: We will correlate molecular markers of Q cell with other genetic alterations
timeFrame: 3-5 days postoperatively
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Glioma Centre
state: Guangdong
Study officials:
affiliation: Nanfang Glioma centre, Guangzhou, China
name: Songtao Qi, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: Sturm D, Witt H, Hovestadt V, Khuong-Quang DA, Jones DT, Konermann C, Pfaff E, Tonjes 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, Fruhwald MC, Hauch H, Pekrun A, Radlwimmer B, Niehues T, von Komorowski G, Durken 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.