GBMNCT03005132
Integrative Analysis of Human Glioblastoma Multiforme
An observational study of GBM, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Integrative analysis of GBM Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- GBM
- What is being tested?
- Normal brain tissue
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with GBM
Who may be able to join
- Age ≤ 75 years with histologically proven GBM
- No severe major organ dysfunction
- World Health Organization (WHO) performance status of 0 or 1
- No prior cancer chemotherapy
Who cannot join
- Age ≥ 76
- Severe major organ dysfunction
- WHO performance status of >1
- Prior cancer chemotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Da Fu, PhD, 00-86-21-66301604, fu800da900@126.com
Yushui Ma, PhD
About this study
Integrative analysis of GBM
Read the detailed description
The investigators will analyzed proteomes of paired normal brain tissues and GBM, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal brain tissue, primary GBM carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of GBM characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.
- Conditions
- GBM
- Being tested
- Normal brain tissue
- Keywords
- GBM; Integrative Analysis; WES
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal brain tissueOther
The investigators will extract total protein, DNA and RNA from the samples.
| Study group | Role | What they receive |
|---|---|---|
| Normal brain tissue | Normal brain tissue from GBM patients Receives: Other: Normal brain tissue | |
| GBM tissues | GBM tissues from GBM patients Receives: Other: Normal brain tissue | |
| Metastasis tissues | Metastasis tissues from GBM patients Receives: Other: Normal brain tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 years overall survival
Measured: 5 years
Secondary outcomes (3)
5 years disease-free survival
Measured: 5 years
10 years overall survival
Measured: 10 years
10 years disease-free survival
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GBMStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jilin University, Ganzhou City People's Hospital
- Responsible party
- Principal investigator, Da Fu, Shanghai 10th People's Hospital
- Investigators
- Da Fu, PhD, Principal investigator, Shanghai 10th People's HospitalXiaoming Zhong, MD, Study director, Ganzhou City People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005132
- Sponsor's protocol ID
- 2016-521-Rainy
- Status last verified
- Dec 2016
- First submitted
- 23 Dec 2016
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The investigators are willing to share data.
Publications
Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
PubMed 25651787
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Analysis of Human Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT03005132
- Acronym / sponsor ID
- 2016-521-Rainy
- Conditions
- GBM
- Keywords
- GBM; Integrative Analysis; WES
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Collaborators
- Jilin University, Ganzhou City People's Hospital
- Study start
- Jan 2016
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Dec 2016 (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.
Integrative analysis of GBM
Detailed description
The investigators will analyzed proteomes of paired normal brain tissues and GBM, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal brain tissue, primary GBM carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of GBM characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal brain tissue | – | Other: Normal brain tissueNormal brain tissue from GBM patients |
| GBM tissues | – | Other: Normal brain tissueGBM tissues from GBM patients |
| Metastasis tissues | – | Other: Normal brain tissueMetastasis tissues from GBM patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with GBM
Key inclusion criteria (4 listed)
- Age ≤ 75 years with histologically proven GBM
- No severe major organ dysfunction
- World Health Organization (WHO) performance status of 0 or 1
- No prior cancer chemotherapy
Key exclusion criteria (4 listed)
- Age ≥ 76
- Severe major organ dysfunction
- WHO performance status of >1
- Prior cancer chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal brain tissueThe investigators will extract total protein, DNA and RNA from the samples. | Other | GBM tissues, Metastasis tissues, Normal brain tissue |
Primary outcome
5 years overall survival
Time frame: 5 years
3 secondary outcomes
5 years disease-free survival
Time frame: 5 years
10 years overall survival
Time frame: 10 years
10 years disease-free survival
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Results publication: PubMed 25651787Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
- Individual participant dataSharing planned: Yes. The investigators are willing to share data.
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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.
Da Fu, PhD principal investigator
Shanghai 10th People's Hospital
Xiaoming Zhong, MD study director
Ganzhou City People's Hospital
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 GBM, run by Shanghai 10th People's Hospital 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: looking for participants now, as of the sponsor's last update on 29 Dec 2016. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Da Fu, PhD (00-86-21-66301604, fu800da900@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 years overall survival (time frame: 5 years). 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 NCT03005132, which also lists 1 linked publication.
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 29 Dec 2016.