NCT04904419

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

May 23, 2021

Last Update Submit

April 14, 2023

Conditions

Glioma, Malignant

Outcome Measures

Primary Outcomes (1)

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

    Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e

Interventions

Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600eDIAGNOSTIC_TEST

Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \. Glioma patients with Informed Consent Form 2. Glioma patients with intact clinical information

You may not qualify if:

  • \. Glioma patients without Informed Consent Form 2. Glioma patients without intact clinical information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, China

Location

Huashan Hospital(West campus)

Shanghai, China

Location

Huashan Hospital

Shanghai, China

Location

General Hospital of Ningxia Medical University

Yinchuan, China

Location

Related Publications (1)

  • Wu J, Wu S, Cao D, Xiong Z, Zhang J, Zou Y, Wu Z, Nie Y, Luo C, Yao Y, Song Y, Jiao Y, Chen H, Ma H, Kang D, Mao Y, Yan H. Rapid diagnosis of adult-type diffuse glioma using a layered scheme. BMC Med. 2025 Jun 2;23(1):325. doi: 10.1186/s12916-025-04124-9.

    PMID: 40457320DERIVED

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

May 23, 2021

First Posted

May 27, 2021

Study Start

August 1, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)