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

NCT ID: NCT02047058

Last Updated: 2014-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-03-31

Brief Summary

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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

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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.

Conditions

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Glioblastoma Malignant Glioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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high-risk

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangzhou General Hospital of Guangzhou Military Command

OTHER

Sponsor Role collaborator

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

Capital Medical University

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Shenzhen Second People's Hospital

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

First Hospital of China Medical University

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role collaborator

Guangzhou First People's Hospital

OTHER

Sponsor Role collaborator

Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Southern Medical University, China

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Songtao Qi, Doctor

Role: PRINCIPAL_INVESTIGATOR

Nanfang Glioma centre, Guangzhou, China

Locations

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Nanfang Glioma Centre

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Songtao Qi, Doctor

Role: CONTACT

+8620-61641804

Lei Yu, Doctor

Role: CONTACT

+8620-61641806

References

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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.

Reference Type BACKGROUND
PMID: 22034964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21874255 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23079654 (View on PubMed)

Other Identifiers

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NFGC-001-MCP

Identifier Type: -

Identifier Source: org_study_id

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