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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03750890
Other study ID # ZWZ2018
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2022

Study information

Verified date November 2018
Source Tongji Hospital
Contact Wenzhen Zhu, doctor
Phone 8613886018612
Email zhuwenzhen8612@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

1. postoperative pathological and genetic test confirmed brain glioma;

2. The preoperative Clear and complete multimodal imaging data were collected within 10 days.

Exclusion Criteria:

1. patients who underwent surgery more than 4 weeks after MRI;

2. patients with motion artifacts.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Zhenxiong Wang Wuhan Choose A State Or Province

Sponsors (1)

Lead Sponsor Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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