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NCT04904419 Clinical Trial

Multi-center Research Project for Glioma Molecular Pathology Intraoperative Rapid Detection

Glioma, Malignant Clinical Trial

Official title:
Multi-center Research Project for Glioma Molecular Pathology Intraoperative Rapid Detection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04904419
Other study ID # KY2020-1298
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date January 31, 2022

Study information
Verified date April 2023
Source Huashan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.

Recruitment information / eligibility
Status Completed
Enrollment 137
Est. completion date January 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 1. Glioma patients with Informed Consent Form 2. Glioma patients with intact clinical information Exclusion Criteria: - 1. Glioma patients without Informed Consent Form 2. Glioma patients without intact clinical information

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e
Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e

Locations
Country Name City State
China The First Affiliated Hospital of Fujian Medical University Fuzhou
China Huashan Hospital Shanghai
China Huashan Hospital(West campus) Shanghai
China General Hospital of Ningxia Medical University Yinchuan

Sponsors (1)
Lead Sponsor Collaborator
Jinsong Wu

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e
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