Multi-center Research Project for Glioma Molecular Pathol... | NCT04904419

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

NCT04904419

Sponsor

Jinsong Wu

Status

Completed

Last Update Posted

Apr 18, 2023Actual

Enrollment

137Actual

Phase

Not provided

Conditions

Glioma, Malignant

Interventions

Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2021Actual

Primary Completion Date

Jan 31, 2022Actual

Completion Date

Jan 31, 2022Actual

First Submitted Date

May 23, 2021

First Submission Date that Met QC Criteria

May 23, 2021

First Posted Date

May 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2023

Last Update Posted Date

Apr 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

137Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e	Diagnostic Test	Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Glioma patients with Informed Consent Form
Glioma patients with intact clinical information

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Fujian Medical University		Fuzhou			China
Huashan Hospital(West campus)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40457320	Derived	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.

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type