Glioma, MalignantNCT04924127
Molecular Pathology Research Project of Glioma
An observational study of Glioma, Malignant, run by Jinsong Wu at 1 site in China.
Trial summary
Evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes and expend the application of the diagnostic algorithm to surgical practice Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioma, Malignant
- What is being tested?
- Detection of IDH and TERT mutation
- How many people
- 976 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2019to 20 Dec 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Glioma patient from Huashan Hospital with Informed Consent Form
Who may be able to join
- Clinical diagnosis of Glioma
- Glioma patient with long-term follow-up data and intact clinical data
Who cannot join
- Glioma patient without Informed Consent Form
- Glioma patient without long-term follow-up data or intact clinical data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Feasibility of the Molecular Pathology Model of Patients With Glioma Via Retrospective Research
Evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes and expend the application of the diagnostic algorithm to surgical practice
Read the detailed description
A total of 976 gliomas were enrolled in this study. First, in order to evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes, we conducted a retrospective cohort study included 753 frozen tissue samples of patients with different grades of glioma. According to WHO CNS5, all recommended alteration including IDH, 1p/19q, TERT, EGFRamp and 7+/10- were profiled using multiple approaches and a permanent diagnosis was obtained for each patient. Exploring the feasibility of the molecular pathology model of patients with glioma via retrospective research. Compare with the existing molecular pathology system, analyze the combination of IDH and TERT mutations and the feasibility of stratifying the prognosis of patients with glioma.
Moreover, to expend the application of the diagnostic algorithm to surgical practice, we developed a fast detection assay that could detect hotspot somatic mutations in IDH and TERT within 25 minutes and can discriminate TERT and IDH mutations from wild-type alleles with a minimum variant allele frequency (VAF) of 0.2% and 0.5%, respectively. We further validate the simplified diagnostic algorithm on frozen tissue of 223 patients with glioma in another retrospective cohort and performed this assay to evaluate the accuracy of the rapid assay.
- Conditions
- Glioma, Malignant
- Being tested
- Detection of IDH and TERT mutation
- Keywords
- Molecular pathology
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of IDH and TERT mutationDiagnostic test
Detection of IDH and TERT mutation using frozen glioma tissues
| Study group | Role | What they receive |
|---|---|---|
| Discovery cohort | Retrospective frozen tissue and paired peripheral blood samples were obtained from the Huashan Glioma Biobank between October 2010 and August 2018. A total of 753 patients diagnosed with supratentorial diffuse glioma (WHO grade 2-4) aged 18-80 years were selected for the study. Receives: Diagnostic Test: Detection of IDH and TERT mutation | |
| Validation cohort | From January to July 2021, 223 frozen tissue samples were retrieved from the Huashan Glioma Biobank. In addition, 107 frozen tumor samples were used to assess the detection accuracy of the IDH and TERTp mutation rapid test. The accuracy of this qPCR-based rapid test was further confirmed by Sanger and targeted sequencing. Receives: Diagnostic Test: Detection of IDH and TERT mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes
According to WHO CNS5, all recommended alteration including IDH, 1p/19q, TERT, EGFRamp and 7+/10- were profiled using multiple approaches and a permanent diagnosis was obtained for each patient. Exploring the feasibility of the molecular pathology model of patients with glioma
Measured: through study completion, an average of 1 week
Derivation and validation of a simplified diagnostic scheme
Derivation of a simplified diagnostic scheme based on IDH and TERT promoter (TERTp) mutations combined with histology and evaluation of its feasibility of stratifying the prognosis of patients with glioma when comparing with WHO CNS5 criteria.
Measured: through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start5 Dec 2019
- Primary completion6 Jun 2021
- Study completion20 Dec 2021
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 Glioma, MalignantStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 976 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinsong Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jinsong Wu, Huashan Hospital
- Investigators
- Jin-song Wu, MD & PhD, Study chair, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924127
- Sponsor's protocol ID
- KY2019-539
- Status last verified
- Apr 2023
- First submitted
- 23 May 2021
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu J, Wu S, Cao D, Xiong Z, Zhang J, Zou Y, Wu Z, Nie Y, Luo C, Yao Y, Song Y, Jiao Y, Chen H, Ma H, Kang D, Mao Y, Yan H. Rapid diagnosis of adult-type diffuse glioma using a layered scheme. BMC Med. 2025 Jun 2;23(1):325. doi: 10.1186/s12916-025-04124-9.
PubMed 40457320
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility of the Molecular Pathology Model of Patients With Glioma Via Retrospective Research
- ClinicalTrials.gov ID
- NCT04924127
- Acronym / sponsor ID
- KY2019-539
- Conditions
- Glioma, Malignant
- Keywords
- Molecular pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 976 participants (actual)
- Lead sponsor
- Jinsong WuUniversity, hospital or other
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 6 Jun 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 11 Jun 2021 (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.
Evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes and expend the application of the diagnostic algorithm to surgical practice
Detailed description
A total of 976 gliomas were enrolled in this study. First, in order to evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes, we conducted a retrospective cohort study included 753 frozen tissue samples of patients with different grades of glioma. According to WHO CNS5, all recommended alteration including IDH, 1p/19q, TERT, EGFRamp and 7+/10- were profiled using multiple approaches and a permanent diagnosis was obtained for each patient. Exploring the feasibility of the molecular pathology model of patients with glioma via retrospective research. Compare with the existing molecular pathology system, analyze the combination of IDH and TERT mutations and the feasibility of stratifying the prognosis of patients with glioma.
Moreover, to expend the application of the diagnostic algorithm to surgical practice, we developed a fast detection assay that could detect hotspot somatic mutations in IDH and TERT within 25 minutes and can discriminate TERT and IDH mutations from wild-type alleles with a minimum variant allele frequency (VAF) of 0.2% and 0.5%, respectively. We further validate the simplified diagnostic algorithm on frozen tissue of 223 patients with glioma in another retrospective cohort and performed this assay to evaluate the accuracy of the rapid assay.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discovery cohort | – | Diagnostic Test: Detection of IDH and TERT mutationRetrospective frozen tissue and paired peripheral blood samples were obtained from the Huashan Glioma Biobank between October 2010 and August 2018. A total of 753 patients diagnosed with supratentorial diffuse glioma (WHO grade 2-4) aged 18-80 years were selected for the study. |
| Validation cohort | – | Diagnostic Test: Detection of IDH and TERT mutationFrom January to July 2021, 223 frozen tissue samples were retrieved from the Huashan Glioma Biobank. In addition, 107 frozen tumor samples were used to assess the detection accuracy of the IDH and TERTp mutation rapid test. The accuracy of this qPCR-based rapid test was further confirmed by Sanger and targeted sequencing. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Glioma patient from Huashan Hospital with Informed Consent Form
Key inclusion criteria (2 listed)
- Clinical diagnosis of Glioma
- Glioma patient with long-term follow-up data and intact clinical data
Key exclusion criteria (2 listed)
- Glioma patient without Informed Consent Form
- Glioma patient without long-term follow-up data or intact clinical data
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 |
|---|---|---|
| Detection of IDH and TERT mutationDetection of IDH and TERT mutation using frozen glioma tissues | Diagnostic test | Discovery cohort, Validation cohort |
Primary outcome
Evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes
Time frame: through study completion, an average of 1 week
According to WHO CNS5, all recommended alteration including IDH, 1p/19q, TERT, EGFRamp and 7+/10- were profiled using multiple approaches and a permanent diagnosis was obtained for each patient. Exploring the feasibility of the molecular pathology model of patients with glioma
Derivation and validation of a simplified diagnostic scheme
Time frame: through study completion, an average of 1 week
Derivation of a simplified diagnostic scheme based on IDH and TERT promoter (TERTp) mutations combined with histology and evaluation of its feasibility of stratifying the prognosis of patients with glioma when comparing with WHO CNS5 criteria.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Derived from this study: PubMed 40457320Wu J, Wu S, Cao D, Xiong Z, Zhang J, Zou Y, Wu Z, Nie Y, Luo C, Yao Y, Song Y, Jiao Y, Chen H, Ma H, Kang D, Mao Y, Yan H. Rapid diagnosis of adult-type diffuse glioma using a layered scheme. BMC Med. 2025 Jun 2;23(1):325. doi: 10.1186/s12916-025-04124-9.
- Individual participant dataSharing planned: No
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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.
Jin-song Wu, MD & PhD study chair
Huashan 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 Glioma, Malignant, run by Jinsong Wu 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: finished, as of the sponsor's last update on 19 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the diagnostic value of TERT promoter mutation in differ glioma subtypes (time frame: through study completion, an average of 1 week). 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 NCT04924127, 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 19 Apr 2023.