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Survival Significance of Molecular Pathology and Genetic Variation in Brain Gliomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216537
Recruitment Status : Recruiting
First Posted : January 2, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Zhenyu Zhang, The First Affiliated Hospital of Zhengzhou University

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
Glioma Molecular Sequence Variation Genetic Change 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.

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Study Type : Observational
Estimated 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 : January 1, 2018
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Glioma groups based on molecular pathology or genetic variation
    Patients with newly diagnosed glioma that receive tumor resection


Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From enrollment to death of patients. Estimated about 5 years. ]
    The length of time from enrollment until the time of death (OS, overall survival)


Biospecimen Retention:   Samples With DNA
All participants have signed the informed consent. Fresh frozen tissues of participants are collected immediately after tumor resection and preserved in liquid nitrogen. Whole exome sequencing, RNA sequencing and proteomics are planed to be conducted.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year to 95 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects are all received tumor resection in the First Affiliated Hospital of Zhengzhou University.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216537


Contacts
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Contact: Zhenyu Zhang, Dr. +86 17839973727 fcczhangzy1@zzu.edu.cn

Locations
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China, Henan
Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Zhenyu Zhang, Dr.    +86 17839973727    fcczhangzy1@zzu.edu.cn   
Sponsors and Collaborators
The First Affiliated Hospital of Zhengzhou University

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Responsible Party: Zhenyu Zhang, Doctor, The First Affiliated Hospital of Zhengzhou University
ClinicalTrials.gov Identifier: NCT04216537    
Other Study ID Numbers: GiomaMG-1
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhenyu Zhang, The First Affiliated Hospital of Zhengzhou University:
Survival
Subgroup
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue