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

NCT ID: NCT04904419

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioma, Malignant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e

Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jinsong Wu

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jinsong Wu

Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of Fujian Medical University

Fuzhou, , China

Site Status

Huashan Hospital(West campus)

Shanghai, , China

Site Status

Huashan Hospital

Shanghai, , China

Site Status

General Hospital of Ningxia Medical University

Yinchuan, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40457320 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KY2020-1298

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.