Evaluate the Effectiveness and Safety of Raman IVD Analyzer in the Molecular Diagnosis of Gliomas During Surgery

NCT06363162 | Recruiting

• 1 other identifier: LRR202404
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 results of Immunohistochemistry or genetic test on the same brain tissue samples.

Conditions

Glioma

Keywords

Molecular subtype; Raman; intraoperative; surgery

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (7)

• Sensitivity

  Through study completion, an average of 1 year

• Specificity

  Through study completion, an average of 1 year

• Kappa coefficient

  Through study completion, an average of 1 year

• Time consumption for the Raman analyzer in detection

  Through study completion, an average of 1 year

• Adverse Event Incidence Rate

  During the surgery

Study Arms (1)

Perform two different tests on the same sample

EXPERIMENTAL

Perform the diagnosis of Raman analyzer and immunohistochemistry or genetic test on the same sample.

Diagnostic Test: Immunohistochemistry or genetic test

Interventions

Immunohistochemistry or genetic test DIAGNOSTIC_TEST

Perform two diagnostic methods on the same sample

Also known as: Raman analyzer diagnosis

Perform two different tests on the same sample

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• West China Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Capital Medical University: collaborator
• Jiangsu Raman Medical Equipment Co., Ltd.: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100071, China

RECRUITING

MeSH Terms

Conditions

Glioma

Interventions

Immunohistochemistry; Genetic Testing

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Qing Mao

  West China Hospital

  PRINCIPAL INVESTIGATOR

• Dongming Yan

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

• Shouwei Li

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang Yinyan, MD and PhD

CONTACT

+86 13581698953; tiantanyinyan@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blind assessment: Researchers using Raman analyzer during surgery are not aware of the subjects' preoperative diagnostic results, while researchers conducting immunohistochemistry or genetic test after surgery are not aware of the subjects' preoperative diagnostic results and the diagnostic results of Raman analyzer.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: December 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

CN (1)