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

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: NCT03668522
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Yuntao Lu, Southern Medical University, China

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

Condition or disease Intervention/treatment
Spinal Tumor Other: Genetic testing

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Clinical Research of the Molecular Phenotype Distribution of H3F3AK27M in Spinal Glioma and Its Impact on TMZ Chemoradiotherapy
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. positive [ Time Frame: through study completion, an average of 1 year ]
    positive of H3F3AK27M



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Surgical treatment and pathological confirmation of spinal glioma in our department.
Criteria

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.

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): NCT03668522


Contacts
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Contact: Lu Yuntao, M.D., Ph.D 13632101002 lllu2000@163.com

Locations
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China, Guangdong
Nan fang hospital, Southern medical university Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Chongyuan Xu, Ph.D    +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         
Sponsors and Collaborators
Southern Medical University, China
Investigators
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Study Chair: Lu Yuntao, M.D., Ph.D Nanfang Hospital Neurosurgery Department

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Responsible Party: Yuntao Lu, adjunct professor, Southern Medical University, China
ClinicalTrials.gov Identifier: NCT03668522     History of Changes
Other Study ID Numbers: SouthernMUC Neurospine-1
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: 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 Yuntao Lu, Southern Medical University, China:
H3F3AK27M
Additional relevant MeSH terms:
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Spinal Cord Neoplasms
Spinal Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Bone Neoplasms
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases