Clinical Research of H3F3AK27M in Spinal Glioma and Its I... | NCT03668522

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

NCT03668522

Sponsor

Southern Medical University, China

Status

Unknown status

Last Update Posted

Sep 12, 2018Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Spinal Tumor

Interventions

Genetic testing

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2018Estimated

Primary Completion Date

Jan 2020Estimated

Completion Date

Jan 2020Estimated

First Submitted Date

Sep 3, 2018

First Submission Date that Met QC Criteria

Sep 11, 2018

First Posted Date

Sep 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2018

Last Update Posted Date

Sep 12, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yuntao Lu, adjunct professor, Southern Medical University, ChinaPrincipal Investigator

Lead Sponsor

Southern Medical University, ChinaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
children		age<=17	Other: Genetic testing
adult		age>17	Other: Genetic testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Genetic testing	Other	To determine whether H3F3AK27M exist in spinal glioma	adult children

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lu Yuntao, M.D., Ph.D	Contact	13632101002		lllu2000@163.com

Overall Officials

Name	Affiliation	Role
Lu Yuntao, M.D., Ph.D	Nanfang Hospital Neurosurgery Department	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nan fang hospital, Southern medical university	Recruiting	Guangzhou	Guangdong	510515	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013120	Spinal Cord Neoplasms

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005820	Genetic Testing

Ancestor Terms

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided