GliomaNCT04216537
Survival Significance of Molecular Pathology and Genetic Variation in Brain Gliomas
An observational study of Glioma and Molecular Sequence Variation, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
This study aims to collect clinical, radiological, pathological, molecular and genetic data including detailed clinical parameters, MR and histopathology images, molecular pathology and genetic data. Read more about this study
- Who is it for?
- Ages 1 year to 95 years
- Conditions the study is for
- Glioma, Molecular Sequence Variation, Genetic Change
- What is being tested?
- Glioma groups based on molecular pathology or genetic variation
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jun 2025
- 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 1 year to 95 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects are all received tumor resection in the First Affiliated Hospital of Zhengzhou University.
Who may be able to join
- Patients must have radiologically and histologically confirmed diagnosis of primary glioma
- Life expectancy of greater than 3 months
- Must receive tumor resection
- Must have sufficient fresh frozen tissues for NGS
- Signed informed consent
Who cannot join
- No gliomas
- No sufficient amount of tumor tissues for detection of molecular pathology
- Patients who are pregnant or breast feeding
- Patients who are suffered from severe systematic malfunctions
- Do not have sufficient fresh frozen tissues for NGS
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Zhenyu Zhang, Dr., +86 17839973727, fcczhangzy1@zzu.edu.cn
About this study
Official title: Survival Significance and Clinical Characteristics of Molecular Pathology and Genetic Variation in Brain Gliomas
This study aims to collect clinical, radiological, pathological, molecular and genetic data including detailed clinical parameters, MR and histopathology images, molecular pathology and genetic data. This study seeks to find the prognostic and clinical significance based on molecular and genetic biomarkers/subgroups of gliomas.
Read the detailed description
Precise classification based on molecular and genetic biomarkers/subgroups for gliomas is challenging. This study aims to collect clinical, radiological, pathological, molecular and genetic data including detailed clinical parameters, MR and histopathology images, molecular pathology (1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations, etc) and genetic data (Whole exome sequencing, RNA sequencing, proteomics, etc). This study seeks to find the prognostic and clinical significance based on molecular and genetic biomarkers/subgroups of gliomas.
- Conditions
- Glioma, Molecular Sequence Variation, Genetic Change
- Being tested
- Glioma groups based on molecular pathology or genetic variation
- Keywords
- Survival, Subgroup
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glioma groups based on molecular pathology or genetic variationDiagnostic test
Patients with newly diagnosed glioma that receive tumor resection
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
The length of time from enrollment until the time of death (OS, overall survival)
Measured: From enrollment to death of patients. Estimated about 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Jan 2018
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou 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
- Other
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenyu Zhang, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216537
- Sponsor's protocol ID
- GiomaMG-1
- Status last verified
- Feb 2021
- First submitted
- 31 Dec 2019
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival Significance and Clinical Characteristics of Molecular Pathology and Genetic Variation in Brain Gliomas
- ClinicalTrials.gov ID
- NCT04216537
- Acronym / sponsor ID
- GiomaMG-1
- Conditions
- Glioma, Molecular Sequence Variation, Genetic Change
- Keywords
- Survival, Subgroup
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 2 Jan 2020 (actual)
- 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.
This study aims to collect clinical, radiological, pathological, molecular and genetic data including detailed clinical parameters, MR and histopathology images, molecular pathology and genetic data. This study seeks to find the prognostic and clinical significance based on molecular and genetic biomarkers/subgroups of gliomas.
Detailed description
Precise classification based on molecular and genetic biomarkers/subgroups for gliomas is challenging. This study aims to collect clinical, radiological, pathological, molecular and genetic data including detailed clinical parameters, MR and histopathology images, molecular pathology (1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations, etc) and genetic data (Whole exome sequencing, RNA sequencing, proteomics, etc). This study seeks to find the prognostic and clinical significance based on molecular and genetic biomarkers/subgroups of gliomas.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 1 year to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects are all received tumor resection in the First Affiliated Hospital of Zhengzhou University.
Key inclusion criteria (5 listed)
- Patients must have radiologically and histologically confirmed diagnosis of primary glioma
- Life expectancy of greater than 3 months
- Must receive tumor resection
- Must have sufficient fresh frozen tissues for NGS
- Signed informed consent
Key exclusion criteria (5 listed)
- No gliomas
- No sufficient amount of tumor tissues for detection of molecular pathology
- Patients who are pregnant or breast feeding
- Patients who are suffered from severe systematic malfunctions
- Do not have sufficient fresh frozen tissues for NGS
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 |
|---|---|---|
| Glioma groups based on molecular pathology or genetic variationPatients with newly diagnosed glioma that receive tumor resection | Diagnostic test | – |
Primary outcome
Overall Survival (OS)
Time frame: From enrollment to death of patients. Estimated about 5 years.
The length of time from enrollment until the time of death (OS, overall survival)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Individual participant dataSharing planned: Undecided. Undecided
Related trials for Glioma
Active, not recruitingPhase 1/2
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Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
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A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
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Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
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.
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 Glioma and Molecular Sequence Variation, run by The First Affiliated Hospital of Zhengzhou 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 5 inclusion and 5 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 8 Feb 2021. 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 Zhenyu Zhang, Dr. (+86 17839973727, fcczhangzy1@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: From enrollment to death of patients. Estimated about 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2021.