Spinal TumorNCT03668522
Clinical Research of H3F3AK27M in Spinal Glioma and Its Impact on TMZ Chemoradiotherapy
An observational study of Spinal Tumor, run by Southern Medical University, China at 1 site in China.
Trial summary
H3F3AK27M may be a feature of primary spinal cord glioma and affect the outcome and prognosis of TMZ chemoradiotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Tumor
- What is being tested?
- Genetic testing
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2018to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Surgical treatment and pathological confirmation of spinal glioma in our department.
Who may be able to join
- Surgical treatment and pathological confirmation of spinal glioma in our department and is the first case without any treatment before operation.
Who cannot join
- The tumor is recurrent or has been treated before operation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nan fang hospital, Southern medical university
Guangzhou, Guangdong, 510515
Chongyuan Xu, Ph.D, +8620-62787238
Yuntao Lu, M.D., Ph.D
About this study
Official title: 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.
- Conditions
- Spinal Tumor
- Being tested
- Genetic testing
- Keywords
- H3F3AK27M
- Medical subject headings
- Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic testingOther
To determine whether H3F3AK27M exist in spinal glioma
| Study group | Role | What they receive |
|---|---|---|
| children | age<=17 Receives: Other: Genetic testing | |
| adult | age>17 Receives: Other: Genetic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive
positive of H3F3AK27M
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study startSep 2018 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuntao Lu, Southern Medical University, China
- Investigators
- Lu Yuntao, M.D., Ph.D, Study chair, Nanfang Hospital Neurosurgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668522
- Sponsor's protocol ID
- SouthernMUC Neurospine-1
- Status last verified
- Sep 2018
- First submitted
- 3 Sep 2018
- Last updated
- 12 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research of the Molecular Phenotype Distribution of H3F3AK27M in Spinal Glioma and Its Impact on TMZ Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT03668522
- Acronym / sponsor ID
- SouthernMUC Neurospine-1
- Conditions
- Spinal Tumor
- Keywords
- H3F3AK27M
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Southern Medical University, ChinaUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
H3F3AK27M may be a feature of primary spinal cord glioma and affect the outcome and prognosis of TMZ chemoradiotherapy.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children | – | Other: Genetic testingage<=17 |
| adult | – | Other: Genetic testingage>17 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Surgical treatment and pathological confirmation of spinal glioma in our department.
Key inclusion criteria (1 listed)
- Surgical treatment and pathological confirmation of spinal glioma in our department and is the first case without any treatment before operation.
Key exclusion criteria (1 listed)
- The tumor is recurrent or has been treated before operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic testingTo determine whether H3F3AK27M exist in spinal glioma | Other | adult, children |
Primary outcome
positive
Time frame: through study completion, an average of 1 year
positive of H3F3AK27M
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu Yuntao, M.D., Ph.D study chair
Nanfang Hospital Neurosurgery Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Tumor, run by Southern Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Yuntao, M.D., Ph.D (13632101002, lllu2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
positive (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.