Glioma, MalignantNCT04904419
Multi-center Research Project for Glioma Molecular Pathology Intraoperative Rapid Detection
An observational study of Glioma, Malignant, run by Jinsong Wu at 4 sites in China.
Trial summary
We explores the accuracy and sensitivity of rapid intraoperative detection of IDH, TERT, BRAF indicators through a prospective clinical multi-center study. This part includes a total of 300 fresh tissue samples, paired blood samples, relevant clinical information and follow-up information from 300 patients with… 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?
- Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e
- How many people
- 137 participants
- Where
- 4 sitesChina
- Study dates
- 1 Aug 2021to 31 Jan 2022
- 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: 1. Glioma patients with Informed Consent Form 2. Glioma patients with intact clinical information
Who may be able to join
- 1. Glioma patients with Informed Consent Form 2. Glioma patients with intact clinical information
Who cannot join
- 1. Glioma patients without Informed Consent Form 2. Glioma patients without intact clinical information
Trial locations and contacts
4 sites in 1 country.
China4 sites
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Huashan Hospital(West campus)
Shanghai
Huashan Hospital
Shanghai
General Hospital of Ningxia Medical University
Yinchuan
About this study
We explores the accuracy and sensitivity of rapid intraoperative detection of IDH, TERT, BRAF indicators through a prospective clinical multi-center study. This part includes a total of 300 fresh tissue samples, paired blood samples, relevant clinical information and follow-up information from 300 patients with different grades of adult glioma. By comparing with the postoperative sequencing results, the specificity and sensitivity of intraoperative IDH and TERT rapid detection results are clear.
- Conditions
- Glioma, Malignant
- Being tested
- Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600eDiagnostic test
Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e
Measured: Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Aug 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
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
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinsong Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jinsong Wu, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904419
- Sponsor's protocol ID
- KY2020-1298
- Status last verified
- Apr 2023
- First submitted
- 23 May 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- 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 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Research Project for Glioma Molecular Pathology Intraoperative Rapid Detection
- ClinicalTrials.gov ID
- NCT04904419
- Acronym / sponsor ID
- KY2020-1298
- Conditions
- Glioma, Malignant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Jinsong WuUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 27 May 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.
We explores the accuracy and sensitivity of rapid intraoperative detection of IDH, TERT, BRAF indicators through a prospective clinical multi-center study. This part includes a total of 300 fresh tissue samples, paired blood samples, relevant clinical information and follow-up information from 300 patients with different grades of adult glioma. By comparing with the postoperative sequencing results, the specificity and sensitivity of intraoperative IDH and TERT rapid detection results are clear.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Glioma patients with Informed Consent Form 2. Glioma patients with intact clinical information
Key inclusion criteria (1 listed)
- 1. Glioma patients with Informed Consent Form 2. Glioma patients with intact clinical information
Key exclusion criteria (1 listed)
- 1. Glioma patients without Informed Consent Form 2. Glioma patients without intact clinical information
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 |
|---|---|---|
| Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600eIntraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e | Diagnostic test | – |
Primary outcome
Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e
Time frame: Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e
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 18 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites 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 4 sites 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 1 inclusion and 1 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 18 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 4 sites 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?
Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e (time frame: Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e). 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 NCT04904419, 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 18 Apr 2023.