NCT03750890

Brief Summary

The key molecular changes in the progression of glioma are closely related to tumor heterogeneity, pathological grade, precision treatment and prognosis of glioma. At present, a visually quantitative assessment criteria about the key molecular typing of glioma is still absent. Based on the previous research, this project intends to establish a multi-dimensional database of glioma from clinical, radiomics and microomics levels. The investigators aim to filter out the specific molecular markers in the progression of glioma and explore the intrinsic connection of radiomics features and microomics molecular markers by using bioinformatics integration analysis and artificial intelligence multiple kernel learning. Thus, the investigators could determine the specific molecular mechanism in the progression of glioma, and establish a visually quantitative assessment system of pre-operative precisive grading, molecular typing discrimination and prognosis prediction. The completion of this project is of great significance for improving molecular diagnostic level of glioma, guiding individualized diagnosis and treatment decisions, and improving the survival rate of patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 20, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 26, 2019

Status Verified

November 1, 2018

Enrollment Period

3 years

First QC Date

November 20, 2018

Last Update Submit

March 24, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • radiomics features(the parameters of T1WI, T2WI, DWI, DKI, ASL, ESWAN, DCE, MRS and so on)

    the radiomics features(the parameters of T1WI, T2WI, DWI, DKI, ASL, ESWAN, DCE, MRS and so on)in the progression of glioma

    through study completion, an average of 3 years

  • microomics molecular markers (IDH mutation, 1p/19q status, P53 mutation, TERT and ATRX mutation, EGFR amplification and mutation, MGMT methylation status, PTEN mutation, ZM fusion gene and other gene features)

    the key molecular markers (IDH mutation, 1p/19q status, P53 mutation, TERT and ATRX mutation, EGFR amplification and mutation, MGMT methylation status, PTEN mutation, ZM fusion gene and other gene features) in the progression of glioma

    through study completion, an average of 3 years

Eligibility Criteria

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

consecutive patients who were suspected of having brain gliomas on the basis of clinical findings and who were previously diagnosed with brain gliomas underwent MRI.

You may qualify if:

  • postoperative pathological and genetic test confirmed brain glioma;
  • The preoperative Clear and complete multimodal imaging data were collected within 10 days.

You may not qualify if:

  • patients who underwent surgery more than 4 weeks after MRI;
  • patients with motion artifacts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhenxiong Wang

Wuhan, Choose A State Or Province, 430030, China

RECRUITING

Central Study Contacts

Wenzhen Zhu, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 23, 2018

Study Start

January 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

March 26, 2019

Record last verified: 2018-11

Locations