Spinal Cord TumorNCT04331431
Outcomes of the Intradural Extramedullary Tumors Resection
A study testing Spinal cord tumor resection in people with Spinal Cord Tumor, run by Sohag University.
Trial summary
The intradural extramedullary tumors remain curable diseases. Our aim in this study is to evaluate the postoperative status after the tumor resection and compare it to the preoperative status Read more about this study
- Who is it for?
- Ages 28 to 66 years
- Conditions the study is for
- Spinal Cord Tumor
- What is being tested?
- Spinal cord tumor resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2008to 8 Apr 2015
- Phase
- Interventional
- 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 28 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- neurological deficit
- back pain
Who cannot join
- old age above 80 years
- immunocompromised patients
About this study
Official title: Professor of Neurosurgery
The intradural extramedullary tumors remain curable diseases. Our aim in this study is to evaluate the postoperative status after the tumor resection and compare it to the preoperative status
Read the detailed description
Meticulous microscopic excision without nerve root or dural injuries
- Conditions
- Spinal Cord Tumor
- Being tested
- Spinal cord tumor resection
- 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.
Spinal cord tumor resectionProcedure or surgery
Excision of intradural tumors
| Study group | Role | What they receive |
|---|---|---|
| spinal cord tumors | Other | Not described Receives: Procedure: Spinal cord tumor resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete excision
delicate dissection
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Apr 2008
- Primary completion1 Apr 2015
- Study completion8 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord TumorStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed salaheldin mohammed saro, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331431
- Sponsor's protocol ID
- Sohag77
- Status last verified
- Mar 2020
- First submitted
- 28 Mar 2020
- Last updated
- 2 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Professor of Neurosurgery
- ClinicalTrials.gov ID
- NCT04331431
- Acronym / sponsor ID
- Sohag77
- Conditions
- Spinal Cord Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2008 (actual)
- Primary completion
- 1 Apr 2015 (actual)
- Study completion
- 8 Apr 2015 (actual)
- First posted
- 2 Apr 2020 (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.
The intradural extramedullary tumors remain curable diseases. Our aim in this study is to evaluate the postoperative status after the tumor resection and compare it to the preoperative status
Detailed description
Meticulous microscopic excision without nerve root or dural injuries
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spinal cord tumors | Other | Procedure: Spinal cord tumor resection |
Who may qualify
- Ages
- 28 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- neurological deficit
- back pain
Key exclusion criteria (2 listed)
- old age above 80 years
- immunocompromised patients
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 |
|---|---|---|
| Spinal cord tumor resectionExcision of intradural tumors | Procedure or surgery | spinal cord tumors |
Primary outcome
complete excision
Time frame: 7 years
delicate dissection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal cord tumor resection in people with Spinal Cord Tumor, run by Sohag University.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete excision (time frame: 7 years). 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 2 Apr 2020.