NCT04216537

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.

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
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

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

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

7 years

First QC Date

December 31, 2019

Last Update Submit

February 5, 2021

Conditions

Keywords

SurvivalSubgroup

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

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

    From enrollment to death of patients. Estimated about 5 years.

Interventions

Patients with newly diagnosed glioma that receive tumor resection

Eligibility Criteria

Age1 Year - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects are all received tumor resection in the First Affiliated Hospital of Zhengzhou University.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

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.

MeSH Terms

Conditions

Glioma

Interventions

Genetic Variation

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 31, 2019

First Posted

January 2, 2020

Study Start

January 1, 2018

Primary Completion

January 1, 2025

Study Completion

June 1, 2025

Last Updated

February 8, 2021

Record last verified: 2021-02

Locations