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

April 14, 2023 updated by: Jinsong Wu
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Fuzhou, China
        • The First Affiliated Hospital Of Fujian Medical University
      • Shanghai, China
        • Huashan Hospital
      • Shanghai, China
        • Huashan Hospital(West campus)
      • Yinchuan, China
        • General Hospital of Ningxia Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  1. Glioma patients with Informed Consent Form
  2. Glioma patients with intact clinical information

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e
Time Frame: Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e
Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinsong Wu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

May 23, 2021

First Submitted That Met QC Criteria

May 23, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2020-1298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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