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

Last updated: April 9, 2024
Sponsor: Beijing Tiantan Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer/tumors

Brain Cancer

Brain Tumor

Treatment

Immunohistochemistry or genetic test

Clinical Study ID

NCT06363162
LRR202404
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who plan to undergo brain lesion tissue resection surgery or havepreoperative clinical diagnosis of gliomas and plan to undergo biopsy;
  • Patients with clinical diagnosis of initial solitary gliomas, or initial solitaryintracranial masses or initial non occupying lesions that do not exclude gliomas (suchas intracranial metastatic lesions, intracranial infectious lesions, intracranialdemyelinating lesions, central nervous system lymphoma, etc.), who have not receivedradiotherapy or chemotherapy in the past based on their medical history;
  • The patient or their guardian can understand the research purpose, demonstratesufficient compliance with the trial protocol, consent for immunohistochemistry orgenetic 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 masslesions but maybe with gliomas should be taken core tissue.

Exclusion

Exclusion Criteria: Investigator judge that it is not suitable for inclusion.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Immunohistochemistry or genetic test
Phase:
Study Start date:
December 01, 2022
Estimated Completion Date:
December 31, 2025

Study 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).

Connect with a study center

  • Beijing Tiantan Hospital

    Beijing, Beijing 100071
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.