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Survival Significance of Molecular Pathology and Genetic Variation in Brain Gliomas

Sponsor
The First Affiliated Hospital of Zhengzhou University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04216537
Collaborator
(none)
3,000
Enrollment
1
Location
89
Anticipated Duration (Months)
33.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to collect clinical, radiological, pathological, molecular and genetic data including detailed clinical parameters, MR and histopathology images, molecular pathology and genetic data. This study seeks to find the prognostic and clinical significance based on molecular and genetic biomarkers/subgroups of gliomas.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Glioma groups based on molecular pathology or genetic variation

Detailed Description

Precise classification based on molecular and genetic biomarkers/subgroups for gliomas is challenging. This study aims to collect clinical, radiological, pathological, molecular and genetic data including detailed clinical parameters, MR and histopathology images, molecular pathology (1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations, etc) and genetic data (Whole exome sequencing, RNA sequencing, proteomics, etc). This study seeks to find the prognostic and clinical significance based on molecular and genetic biomarkers/subgroups of gliomas.

Study Design

Study Type:
Observational
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Survival Significance and Clinical Characteristics of Molecular Pathology and Genetic Variation in Brain Gliomas
Actual Study Start Date :
Jan 1, 2018
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Overall Survival (OS) [From enrollment to death of patients. Estimated about 5 years.]

    The length of time from enrollment until the time of death (OS, overall survival)

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patients must have radiologically and histologically confirmed diagnosis of primary glioma

  • Life expectancy of greater than 3 months

  • Must receive tumor resection

  • Must have sufficient fresh frozen tissues for NGS

  • Signed informed consent

Exclusion Criteria:

  • No gliomas

  • No sufficient amount of tumor tissues for detection of molecular pathology

  • Patients who are pregnant or breast feeding

  • Patients who are suffered from severe systematic malfunctions

  • Do not have sufficient fresh frozen tissues for NGS

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450052

Sponsors and Collaborators

  • The First Affiliated Hospital of Zhengzhou University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhenyu Zhang, Doctor, The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier:
NCT04216537
Other Study ID Numbers:
  • GiomaMG-1
First Posted:
Jan 2, 2020
Last Update Posted:
Feb 8, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhenyu Zhang, Doctor, The First Affiliated Hospital of Zhengzhou University
Survival
Subgroup
Additional relevant MeSH terms:
Glioma

Study Results

No Results Posted as of Feb 8, 2021