Clinical Research of H3F3AK27M in Spinal Glioma and Its Impact on TMZ Chemoradiotherapy

September 11, 2018 updated by: Yuntao Lu, Southern Medical University, China

Clinical Research of the Molecular Phenotype Distribution of H3F3AK27M in Spinal Glioma and Its Impact on TMZ Chemoradiotherapy

H3F3AK27M may be a feature of primary spinal cord glioma and affect the outcome and prognosis of TMZ chemoradiotherapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nan fang hospital, Southern medical university
        • Contact:
          • Chongyuan Xu, Ph.D
          • Phone Number: +8620-62787238
        • Principal Investigator:
          • Yuntao Lu, M.D., Ph.D
        • Sub-Investigator:
          • Lin Pen, M.D.
        • Sub-Investigator:
          • Hai Wang, M.D., Ph.D
        • Sub-Investigator:
          • Jin Shi, Master
        • Sub-Investigator:
          • Junjie Li, Master
        • Sub-Investigator:
          • Lei Chen, Master
        • Sub-Investigator:
          • Zhijian Weng, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Surgical treatment and pathological confirmation of spinal glioma in our department.

Description

Inclusion Criteria:

  • Surgical treatment and pathological confirmation of spinal glioma in our department and is the first case without any treatment before operation.

Exclusion Criteria:

  • The tumor is recurrent or has been treated before operation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
children
age<=17
Other: Genetic testing
To determine whether H3F3AK27M exist in spinal glioma
adult
age>17
Other: Genetic testing
To determine whether H3F3AK27M exist in spinal glioma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
positive
Time Frame: through study completion, an average of 1 year
positive of H3F3AK27M
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern Medical University, China

Investigators

  • Study Chair: Lu Yuntao, M.D., Ph.D, Nanfang Hospital Neurosurgery Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2018

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

September 3, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SouthernMUC Neurospine-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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