GliomaNCT06363162
Evaluate the Effectiveness and Safety of Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery
A study testing Immunohistochemistry or genetic test in people with Glioma, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
To distinguish various molecular subtypes of gliomas by spectra data obtained from Raman analyzer, including IDH mutant, 1p/19q-codeleted, ATRX deletion, TERT promoter mutation, MGMT promoter methylation, EGFR amplification, H3 K27-altered, TP53 mutant, PTEN deficiency, ki 67, AQP4, VEGF, and so on, comparing with the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioma
- What is being tested?
- Immunohistochemistry or genetic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 31 Dec 2025
- Phase
- Interventional
- 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
Who may be able to join
- Patients who plan to undergo brain lesion tissue resection surgery or have preoperative clinical diagnosis of gliomas and plan to undergo biopsy;
- Patients with clinical diagnosis of initial solitary gliomas, or initial solitary intracranial masses or initial non occupying lesions that do not exclude gliomas (such as intracranial metastatic lesions, intracranial infectious lesions, intracranial demyelinating lesions, central nervous system lymphoma, etc.), who have not received radiotherapy or chemotherapy in the past based on their medical history;
- The patient or their guardian can understand the research purpose, demonstrate sufficient compliance with the trial protocol, consent for immunohistochemistry or genetic test, and sign an informed consent form;
- It is possible to obtain tissue samples with a length diameter greater than 0.2cm. Patients diagnosed with initial solitary glioma should take core or marginal tissue, while patients diagnosed with initial single intracranial mass or initial non mass lesions but maybe with gliomas should be taken core tissue.
Who cannot join
- Investigator judge that it is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100071
Yinyan Wang, MD and PhD, +86 13581698953, tiantanyinyan@126.com
About this study
Official title: Evaluate the Effectiveness and Safety of the Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery, Using Samples From Brain Resection Tissue (Ambispective, Multicenter, Blind Evaluation, Single Group Target Value Method)
To distinguish various molecular subtypes of gliomas by spectra data obtained from Raman analyzer, including IDH mutant, 1p/19q-codeleted, ATRX deletion, TERT promoter mutation, MGMT promoter methylation, EGFR amplification, H3 K27-altered, TP53 mutant, PTEN deficiency, ki 67, AQP4, VEGF, and so on, comparing with the results of Immunohistochemistry or genetic test on the same brain tissue samples.
Read the detailed description
1500 samples were included retrospectively with the spectra data obtained from Raman analyzer to establish clinical intelligence model, modifying the analyzer. Based on statistical calculations, 200 glioma samples will be included in the trial in all trial centers prospectively. Compare the results between the Raman analyzer and Immunohistochemistry or genetic test results. And calculate the AUC, the accuracy, sensitivity, the specificity, and other indicators of Raman analyzer.
During surgery, core tissue samples were taken from subjects. The test samples size:0.2cm<length diameter ≤ 2cm. The sample testing result is based on the Raman test points. Then take the same tissue sample for Immunohistochemistry or genetic test.
Statistical description of all data, including baseline data, all efficacy indicators, and all safety data. The measurement data give the mean, standard deviation, minimum, maximum, median,25 quantile and 75 quantile; Provide frequency and composition ratio for counting data. The baseline data was analyzed using the Full Analysis Set (FAS); The effectiveness analysis adopts FAS and PPS; The security analysis uses the Security Dataset (SS).
- Conditions
- Glioma
- Being tested
- Immunohistochemistry or genetic test
- Keywords
- Molecular subtype, Raman, intraoperative, surgery
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunohistochemistry or genetic testDiagnostic test
Also called Raman analyzer diagnosis
Perform two diagnostic methods on the same sample
| Study group | Role | What they receive |
|---|---|---|
| Perform two different tests on the same sample | Experimental | Perform the diagnosis of Raman analyzer and immunohistochemistry or genetic test on the same sample. Receives: Diagnostic Test: Immunohistochemistry or genetic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve
The Area Under the Curve of the ROC curve illustrates the performance of Raman analyzer for the diagnosis of molecular subtype in glioma, confirmed by immunohistochemistry or genetic test.
Measured: Through study completion, an average of 1 year
Accuracy
The proportion of tissue samples with consistent results between Raman analyzer detection and immunohistochemistry or genetic test.
Measured: Through study completion, an average of 1 year
Secondary outcomes (7)
Sensitivity
Among one kind of molecular subtype samples determined by immunohistochemistry or genetic test, the percentage of samples detected by Raman analyzer as the same molecular subtype.
Measured: Through study completion, an average of 1 year
Specificity
Among one kind of molecular subtype samples determined by immunohistochemistry or genetic test, the percentage of samples detected by Raman analyzer as the different molecular subtype.
Measured: Through study completion, an average of 1 year
Kappa coefficient
Kappa coefficient≥0.75 indicates high consistency; 0.75>Kappa coefficient≥0.4, considered consistent; If the Kappa coefficient is less than 0.4, it is considered inconsistent.
Measured: Through study completion, an average of 1 year
Time consumption for the Raman analyzer in detection
Time required from emitting laser to completing single point detection
Measured: Through study completion, an average of 1 year
Adverse Event Incidence Rate
Number of subjects with AE/total number of subjects ×100%
Measured: During the surgery
Serious Adverse Event Incidence Rate
Number of subjects with SAE/total number of subjects ×100%
Measured: During the surgery
Operator adverse events
Possible damage to device operators during the use and maintenance of the Raman analyzers
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 Dec 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 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 Beijing Tiantan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The same sample was diagnosed using Raman spectroscopy and immunohistochemistry or genetic test, respectively. Calculate the AUC, the accuracy, the sensitivity and specificity of a Raman analyzer using immunohistochemistry or genetic test results as the gold standard.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, The First Affiliated Hospital of Zhengzhou University, Capital Medical University, Jiangsu Raman Medical Equipment Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Qing Mao, Principal investigator, West China HospitalDongming Yan, Principal investigator, The First Affiliated Hospital of Zhengzhou UniversityShouwei Li, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363162
- Sponsor's protocol ID
- LRR202404
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Effectiveness and Safety of the Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery, Using Samples From Brain Resection Tissue (Ambispective, Multicenter, Blind Evaluation, Single Group Target Value Method)
- ClinicalTrials.gov ID
- NCT06363162
- Acronym / sponsor ID
- LRR202404
- Conditions
- Glioma
- Keywords
- Molecular subtype, Raman, intraoperative, surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- West China Hospital, The First Affiliated Hospital of Zhengzhou University, Capital Medical University, Jiangsu Raman Medical Equipment Co., Ltd.
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Apr 2024 (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.
To distinguish various molecular subtypes of gliomas by spectra data obtained from Raman analyzer, including IDH mutant, 1p/19q-codeleted, ATRX deletion, TERT promoter mutation, MGMT promoter methylation, EGFR amplification, H3 K27-altered, TP53 mutant, PTEN deficiency, ki 67, AQP4, VEGF, and so on, comparing with the results of Immunohistochemistry or genetic test on the same brain tissue samples.
Detailed description
1500 samples were included retrospectively with the spectra data obtained from Raman analyzer to establish clinical intelligence model, modifying the analyzer. Based on statistical calculations, 200 glioma samples will be included in the trial in all trial centers prospectively. Compare the results between the Raman analyzer and Immunohistochemistry or genetic test results. And calculate the AUC, the accuracy, sensitivity, the specificity, and other indicators of Raman analyzer.
During surgery, core tissue samples were taken from subjects. The test samples size:0.2cm<length diameter ≤ 2cm. The sample testing result is based on the Raman test points. Then take the same tissue sample for Immunohistochemistry or genetic test.
Statistical description of all data, including baseline data, all efficacy indicators, and all safety data. The measurement data give the mean, standard deviation, minimum, maximum, median,25 quantile and 75 quantile; Provide frequency and composition ratio for counting data. The baseline data was analyzed using the Full Analysis Set (FAS); The effectiveness analysis adopts FAS and PPS; The security analysis uses the Security Dataset (SS).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The same sample was diagnosed using Raman spectroscopy and immunohistochemistry or genetic test, respectively. Calculate the AUC, the accuracy, the sensitivity and specificity of a Raman analyzer using immunohistochemistry or genetic test results as the gold standard.
| Arm | Type | Receives |
|---|---|---|
| Perform two different tests on the same sample | Experimental | Diagnostic Test: Immunohistochemistry or genetic testPerform the diagnosis of Raman analyzer and immunohistochemistry or genetic test on the same sample. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who plan to undergo brain lesion tissue resection surgery or have preoperative clinical diagnosis of gliomas and plan to undergo biopsy;
- Patients with clinical diagnosis of initial solitary gliomas, or initial solitary intracranial masses or initial non occupying lesions that do not exclude gliomas (such as intracranial metastatic lesions, intracranial infectious lesions, intracranial demyelinating lesions, central nervous system lymphoma, etc.), who have not received radiotherapy or chemotherapy in the past based on their medical history;
- The patient or their guardian can understand the research purpose, demonstrate sufficient compliance with the trial protocol, consent for immunohistochemistry or genetic test, and sign an informed consent form;
- It is possible to obtain tissue samples with a length diameter greater than 0.2cm. Patients diagnosed with initial solitary glioma should take core or marginal tissue, while patients diagnosed with initial single intracranial mass or initial non mass lesions but maybe with gliomas should be taken core tissue.
Key exclusion criteria (1 listed)
- Investigator judge that it is not suitable for inclusion.
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 |
|---|---|---|
| Immunohistochemistry or genetic testAlso: Raman analyzer diagnosisPerform two diagnostic methods on the same sample | Diagnostic test | Perform two different tests on the same sample |
Primary outcome
Area Under the Curve
Time frame: Through study completion, an average of 1 year
The Area Under the Curve of the ROC curve illustrates the performance of Raman analyzer for the diagnosis of molecular subtype in glioma, confirmed by immunohistochemistry or genetic test.
Accuracy
Time frame: Through study completion, an average of 1 year
The proportion of tissue samples with consistent results between Raman analyzer detection and immunohistochemistry or genetic test.
7 secondary outcomes
Sensitivity
Time frame: Through study completion, an average of 1 year
Specificity
Time frame: Through study completion, an average of 1 year
Kappa coefficient
Time frame: Through study completion, an average of 1 year
Time consumption for the Raman analyzer in detection
Time frame: Through study completion, an average of 1 year
Adverse Event Incidence Rate
Time frame: During the surgery
Serious Adverse Event Incidence Rate
Time frame: During the surgery
Operator adverse events
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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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.
Qing Mao principal investigator
West China Hospital
Dongming Yan principal investigator
The First Affiliated Hospital of Zhengzhou University
Shouwei Li principal investigator
Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunohistochemistry or genetic test in people with Glioma, run by Beijing Tiantan 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 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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. 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 Wang Yinyan, MD and PhD (+86 13581698953, tiantanyinyan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (time frame: Through study completion, an average of 1 year). 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 12 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.