NCT05100173

Brief Summary

The purpose of this trail is to evaluate the performance of Genetron IDH1 PCR Kit in Glioma patients using real-time PCR method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,192

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

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

Study Start

First participant enrolled

May 13, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2016

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

October 19, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
Last Updated

November 22, 2021

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

October 19, 2021

Last Update Submit

November 12, 2021

Conditions

Glioma, MalignantGlioma, Mixed

Outcome Measures

Primary Outcomes (1)

  • Efficacy of the Genetron IDH1 PCR Kit

    The main purpose of this study is: by evaluating the Genetron IDH1 PCR Kit to compare the results of the Sanger sequencing method, and to calculate the coincidence rate and consistency of the two methods.

    3 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital sample

You may qualify if:

  • Enroll cases in strict accordance with the requirements of the study
  • The remaining samples after routine clinical testing
  • The collection and processing of samples meet the requirements of standard laboratory operations and product instructions
  • The relevant information of the sample is complete, including sample number, gender, age, and possible clinical diagnosis information
  • Each sample must have HE staining results (hematoxylin-eosin staining)
  • Pathological examination diagnosed as glioma, other brain tumors or normal tissues
  • Number of samples: 10 pieces of each sample with a thickness of 10μm, and the tumor content is not less than 50%

You may not qualify if:

  • Incomplete sample information
  • Severely contaminated samples
  • Samples that do not meet the requirements of sample collection and processing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The First Hospital of Jilin University

Jilin, China

Location

Huashan Hospital of Fudan University

Shanghai, China

Location

West China Hospital of Sichuan University

Sichuan, China

Location

The Second Affiliated Hospital of Zhejiang University

Zhejiang, China

Location

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
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2021

First Posted

October 29, 2021

Study Start

May 13, 2016

Primary Completion

September 22, 2016

Study Completion

December 8, 2016

Last Updated

November 22, 2021

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)