Glioma of BrainNCT03750890
Visual Study of Molecular Genotype in Glioma Evolution
An observational study of Glioma of Brain, run by Tongji Hospital at 1 site in China.
Trial summary
The key molecular changes in the progression of glioma are closely related to tumor heterogeneity, pathological grade, precision treatment and prognosis of glioma. At present, a visually quantitative assessment criteria about the key molecular typing of glioma is still absent. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioma of Brain
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2022
- How long will I take part?
- 3 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: consecutive patients who were suspected of having brain gliomas on the basis of clinical findings and who were previously diagnosed with brain gliomas underwent MRI.
Who may be able to join
- postoperative pathological and genetic test confirmed brain glioma;
- The preoperative Clear and complete multimodal imaging data were collected within 10 days.
Who cannot join
- patients who underwent surgery more than 4 weeks after MRI;
- patients with motion artifacts.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhenxiong Wang
Wuhan, Choose A State Or Province, 430030
Zhenxiong Wang, 453839056@qq.com
About this study
Official title: A New Strategy for the Visulation of Molecular Genotype in Glioma Evolution Based on the Radiomics and Microomics
The key molecular changes in the progression of glioma are closely related to tumor heterogeneity, pathological grade, precision treatment and prognosis of glioma. At present, a visually quantitative assessment criteria about the key molecular typing of glioma is still absent. Based on the previous research, this project intends to establish a multi-dimensional database of glioma from clinical, radiomics and microomics levels. The investigators aim to filter out the specific molecular markers in the progression of glioma and explore the intrinsic connection of radiomics features and microomics molecular markers by using bioinformatics integration analysis and artificial intelligence multiple kernel learning. Thus, the investigators could determine the specific molecular mechanism in the progression of glioma, and establish a visually quantitative assessment system of pre-operative precisive grading, molecular typing discrimination and prognosis prediction. The completion of this project is of great significance for improving molecular diagnostic level of glioma, guiding individualized diagnosis and treatment decisions, and improving the survival rate of patients.
- Conditions
- Glioma of Brain
What is being measured
The primary outcome is the main question the study is designed to answer.
radiomics features（the parameters of T1WI, T2WI, DWI, DKI, ASL, ESWAN, DCE, MRS and so on）
the radiomics features（the parameters of T1WI, T2WI, DWI, DKI, ASL, ESWAN, DCE, MRS and so on）in the progression of glioma
Measured: through study completion, an average of 3 years
microomics molecular markers (IDH mutation, 1p/19q status, P53 mutation, TERT and ATRX mutation, EGFR amplification and mutation, MGMT methylation status, PTEN mutation, ZM fusion gene and other gene features)
the key molecular markers (IDH mutation, 1p/19q status, P53 mutation, TERT and ATRX mutation, EGFR amplification and mutation, MGMT methylation status, PTEN mutation, ZM fusion gene and other gene features) in the progression of glioma
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start1 Jan 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma of BrainStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750890
- Sponsor's protocol ID
- ZWZ2018
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2018
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Strategy for the Visulation of Molecular Genotype in Glioma Evolution Based on the Radiomics and Microomics
- ClinicalTrials.gov ID
- NCT03750890
- Acronym / sponsor ID
- ZWZ2018
- Conditions
- Glioma of Brain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 Nov 2018 (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.
The key molecular changes in the progression of glioma are closely related to tumor heterogeneity, pathological grade, precision treatment and prognosis of glioma. At present, a visually quantitative assessment criteria about the key molecular typing of glioma is still absent. Based on the previous research, this project intends to establish a multi-dimensional database of glioma from clinical, radiomics and microomics levels. The investigators aim to filter out the specific molecular markers in the progression of glioma and explore the intrinsic connection of radiomics features and microomics molecular markers by using bioinformatics integration analysis and artificial intelligence multiple kernel learning. Thus, the investigators could determine the specific molecular mechanism in the progression of glioma, and establish a visually quantitative assessment system of pre-operative precisive grading, molecular typing discrimination and prognosis prediction. The completion of this project is of great significance for improving molecular diagnostic level of glioma, guiding individualized diagnosis and treatment decisions, and improving the survival rate of patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- consecutive patients who were suspected of having brain gliomas on the basis of clinical findings and who were previously diagnosed with brain gliomas underwent MRI.
Key inclusion criteria (2 listed)
- postoperative pathological and genetic test confirmed brain glioma;
- The preoperative Clear and complete multimodal imaging data were collected within 10 days.
Key exclusion criteria (2 listed)
- patients who underwent surgery more than 4 weeks after MRI;
- patients with motion artifacts.
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
radiomics features（the parameters of T1WI, T2WI, DWI, DKI, ASL, ESWAN, DCE, MRS and so on）
Time frame: through study completion, an average of 3 years
the radiomics features（the parameters of T1WI, T2WI, DWI, DKI, ASL, ESWAN, DCE, MRS and so on）in the progression of glioma
microomics molecular markers (IDH mutation, 1p/19q status, P53 mutation, TERT and ATRX mutation, EGFR amplification and mutation, MGMT methylation status, PTEN mutation, ZM fusion gene and other gene features)
Time frame: through study completion, an average of 3 years
the key molecular markers (IDH mutation, 1p/19q status, P53 mutation, TERT and ATRX mutation, EGFR amplification and mutation, MGMT methylation status, PTEN mutation, ZM fusion gene and other gene features) in the progression of glioma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
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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.
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 of Brain, run by Tongji 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 2 inclusion and 2 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 26 Mar 2019. 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 Wenzhen Zhu, doctor (8613886018612, zhuwenzhen8612@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiomics features（the parameters of T1WI, T2WI, DWI, DKI, ASL, ESWAN, DCE, MRS and so on） (time frame: through study completion, an average of 3 years). 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?
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 26 Mar 2019.