GliomaNCT05901844
Evaluate the Accuracy of Raman IVD Analyzer in the Diagnosis of Gliomas During Surgery
A study testing Paraffin pathological diagnosis in people with Glioma, run by Beijing Tiantan Hospital.
Trial summary
Compare the data obtained from the Raman analyzer and paraffin pathology examination on the same external brain tissue sample. Evaluate the effectiveness and safety of the Raman analyzer for intraoperative diagnosis gliomas of brain resection tissue samples, using paraffin pathological examination results as clinical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Paraffin pathological diagnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, regardless of gender;
- 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, 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
No sites are listed yet.
About this study
Official title: Evaluate the Effectiveness and Safety of the Raman IVD Analyzer for Intraoperative Glioma Diagnosis, Using Samples From Brain Resection Tissue (Prospective, Multicenter, Blind Evaluation, Single Group Target Value Method)
Compare the data obtained from the Raman analyzer and paraffin pathology examination on the same external brain tissue sample. Evaluate the effectiveness and safety of the Raman analyzer for intraoperative diagnosis gliomas of brain resection tissue samples, using paraffin pathological examination results as clinical reference standards.
Read the detailed description
Based on statistical calculations,108 positive samples and 148 negative samples will be included in the trial in all trial centers. Compare the results between the Raman analyzer and the paraffin pathological. And calculate the sensitivity, the specificity, and other indicators of Raman analyzer.
During surgery, core or marginal 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 paraffin pathological diagnosis.
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
- Paraffin pathological diagnosis
- Keywords
- glioma, 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.
Paraffin pathological diagnosisDiagnostic 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 | Other | The same sample is diagnosed using a Raman analyzer firstly and then diagnosed by paraffin pathology. Receives: Diagnostic Test: Paraffin pathological diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the Raman analyzer in detecting gliomar
Among the samples determined by paraffin pathology as gliomas, the percentage of samples detected by Raman analyzer as gliomas.
Measured: Through study completion, an average of 1 year
Specificity of the Raman analyzer in detecting gliomar
Among the samples determined by paraffin pathology as non gliomas, the percentage of samples detected by the Raman analyzer as non gliomas.
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Using the paraffin test results as a reference, calculate the accuracy of the Raman analyzer in detecting gliomar
The proportion of tissue samples with consistent results between Raman analyzer detection and paraffin pathological diagnosis.
Measured: Through study completion, an average of 1 year
Positive predictive value of the Raman analyzer in detecting gliomar
The percentage of samples diagnosed with glioma by paraffin pathology in the samples detected as glioma by Raman analyzer
Measured: Through study completion, an average of 1 year
Negative predictive value of Raman analyzer in detecting gliomar
The percentage of samples diagnosed with non glioma by paraffin pathology in the samples detected as non glioma by Raman analyzer
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
The Raman analyzer usability evaluation
Use Evaluation Form
Measured: Through study completion, an average of 1 year
Time consumption for the Raman analyzer in detecting gliomar
Time required from emitting laser to completing single point detection
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 posted13 Jun 2023
- Study startJun 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionOct 2024 (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 paraffin pathology, respectively. Calculate the sensitivity and specificity of a Raman analyzer using paraffin pathological results as the gold standard.
- Masking
- None (open label)
- Enrolment
- 256 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
- Tao Jiang, MD and PhD, Principal investigator, Beijing Tiantan HospitalQing 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
- NCT05901844
- Sponsor's protocol ID
- LRR202301
- Status last verified
- Jun 2023
- First submitted
- 24 May 2023
- Last updated
- 13 Jun 2023
- 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 13 Jun 2023. 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 for Intraoperative Glioma Diagnosis, Using Samples From Brain Resection Tissue (Prospective, Multicenter, Blind Evaluation, Single Group Target Value Method)
- ClinicalTrials.gov ID
- NCT05901844
- Acronym / sponsor ID
- LRR202301
- Conditions
- Glioma
- Keywords
- glioma, Raman, intraoperative, surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 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
- Jun 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 13 Jun 2023 (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.
Compare the data obtained from the Raman analyzer and paraffin pathology examination on the same external brain tissue sample. Evaluate the effectiveness and safety of the Raman analyzer for intraoperative diagnosis gliomas of brain resection tissue samples, using paraffin pathological examination results as clinical reference standards.
Detailed description
Based on statistical calculations,108 positive samples and 148 negative samples will be included in the trial in all trial centers. Compare the results between the Raman analyzer and the paraffin pathological. And calculate the sensitivity, the specificity, and other indicators of Raman analyzer.
During surgery, core or marginal 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 paraffin pathological diagnosis.
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 paraffin pathology, respectively. Calculate the sensitivity and specificity of a Raman analyzer using paraffin pathological results as the gold standard.
| Arm | Type | Receives |
|---|---|---|
| Perform two different tests on the same sample | Other | Diagnostic Test: Paraffin pathological diagnosisThe same sample is diagnosed using a Raman analyzer firstly and then diagnosed by paraffin pathology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years old, regardless of gender;
- 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, 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 |
|---|---|---|
| Paraffin pathological diagnosisAlso: Raman analyzer diagnosisPerform two diagnostic methods on the same sample | Diagnostic test | Perform two different tests on the same sample |
Primary outcome
Sensitivity of the Raman analyzer in detecting gliomar
Time frame: Through study completion, an average of 1 year
Among the samples determined by paraffin pathology as gliomas, the percentage of samples detected by Raman analyzer as gliomas.
Specificity of the Raman analyzer in detecting gliomar
Time frame: Through study completion, an average of 1 year
Among the samples determined by paraffin pathology as non gliomas, the percentage of samples detected by the Raman analyzer as non gliomas.
6 secondary outcomes
Using the paraffin test results as a reference, calculate the accuracy of the Raman analyzer in detecting gliomar
Time frame: Through study completion, an average of 1 year
Positive predictive value of the Raman analyzer in detecting gliomar
Time frame: Through study completion, an average of 1 year
Negative predictive value of Raman analyzer in detecting gliomar
Time frame: Through study completion, an average of 1 year
Kappa coefficient
Time frame: Through study completion, an average of 1 year
The Raman analyzer usability evaluation
Time frame: Through study completion, an average of 1 year
Time consumption for the Raman analyzer in detecting gliomar
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 13 Jun 2023.
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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.
Tao Jiang, MD and PhD principal investigator
Beijing Tiantan Hospital
Qing Mao principal investigator
West China Hospital
Dongming Yan principal investigator
The First Affiliated Hospital of Zhengzhou University
Questions about this trial
What is this clinical trial studying?
A study testing Paraffin pathological diagnosis in people with Glioma, run by Beijing Tiantan Hospital.
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 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 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Tao Jiang, MD and PhD (+86 10 67021832, taojiang1964@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the Raman analyzer in detecting gliomar (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 13 Jun 2023.