GlioblastomaNCT02047058
Treatment Response and Prognosis in Glioma Patients: Q Cell and Its Biological Characteristics
An observational study of Glioblastoma and Malignant Glioma, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma, Malignant Glioma
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Mar 2017
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with glioblastoma undergo operation and sufficient tumor specimens
Who may be able to join
- >=18 years old
- Primary Glioblastoma is newly diagnosed and confirmed histologically
- Patient is expected to be treated with temozolomide and followed up routinely at the study site.
- Willing to sign the informed consent
Who cannot join
- Currently enrolled in any other clinical study
- History of any other malignancies
- Refusal to give consent
- No available tumor tissue for IDH analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Glioblastoma, Malignant Glioma
- Keywords
- biomarker, Q cell, Overall survival, Progression-free survival
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| high-risk | high-risk is determined by the evaluation of the biomarkers of Q cell. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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.
Measured: 3-5 days postoperatively
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 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.
Measured: 3-5 days postoperatively
Secondary outcomes (1)
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.
Measured: 3-5 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou General Hospital of Guangzhou Military Command, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, First Affiliated Hospital of Fujian Medical University, The First Affiliated Hospital of Nanchang University, Capital Medical University, Tianjin Medical University General Hospital, Shenzhen Second People's Hospital, Huashan Hospital, West China Hospital, Xiangya Hospital of Central South University, The First Hospital of Jilin University, First Hospital of China Medical University, Qilu Hospital of Shandong University, Second Affiliated Hospital of Soochow University, Sun Yat-sen University, Guangzhou First People's Hospital, Xi'an Jiaotong University, Southern Medical University, China, Second Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Songtao Qi, Doctor, Principal investigator, Nanfang Glioma centre, Guangzhou, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047058
- Sponsor's protocol ID
- NFGC-001-MCP
- Status last verified
- Jan 2014
- First submitted
- 21 Jan 2014
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22034964Qi 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.
PubMed 21874255Sturm 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.
PubMed 23079654
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Observational Study of Analysis of Q Cell Markers in Patients With Newly Diagnosed Primary Glioblastoma (Phase IV)
- ClinicalTrials.gov ID
- NCT02047058
- Acronym / sponsor ID
- NFGC-001-MCP
- Conditions
- Glioblastoma, Malignant Glioma
- Keywords
- biomarker, Q cell, Overall survival, Progression-free survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Guangzhou General Hospital of Guangzhou Military Command, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, First Affiliated Hospital of Fujian Medical University, The First Affiliated Hospital of Nanchang University, Capital Medical University, Tianjin Medical University General Hospital, Shenzhen Second People's Hospital, Huashan Hospital, West China Hospital, Xiangya Hospital of Central South University, The First Hospital of Jilin University, First Hospital of China Medical University, Qilu Hospital of Shandong University, Second Affiliated Hospital of Soochow University, Sun Yat-sen University, Guangzhou First People's Hospital, Xi'an Jiaotong University, Southern Medical University, China, Second Affiliated Hospital of Guangzhou Medical University
- Study start
- Mar 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high-risk | – | –high-risk is determined by the evaluation of the biomarkers of Q cell. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with glioblastoma undergo operation and sufficient tumor specimens
Key inclusion criteria (4 listed)
- >=18 years old
- Primary Glioblastoma is newly diagnosed and confirmed histologically
- Patient is expected to be treated with temozolomide and followed up routinely at the study site.
- Willing to sign the informed consent
Key exclusion criteria (4 listed)
- Currently enrolled in any other clinical study
- History of any other malignancies
- Refusal to give consent
- No available tumor tissue for IDH analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
We will correlate molecular markers of Q cell with other genetic alterations
Time frame: 3-5 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
- Background: PubMed 22034964SongTao 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.
- Background: PubMed 21874255Qi 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.
- Background: PubMed 23079654Sturm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Songtao Qi, Doctor principal investigator
Nanfang Glioma centre, Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma and Malignant Glioma, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Songtao Qi, Doctor (+8620-61641804, yuleiguisi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of each single molecular marker of Q cell on progression-free survival (time frame: 3-5 days postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02047058, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2014.