Spinal Cord TumorNCT05678608
Surgical Outcome of Dorsolumbar Intradural Extramedullary Spinal Cord Tumors
A study testing surgical excision in people with Spinal Cord Tumor, run by Sohag University at 1 site in Egypt.
Trial summary
Primary spinal cord tumors constitute 2-4% of all central nervous system neoplasms; they are classfied as extradural, intradural extramedullary (IDEM: 65%), and intramedullary The most commonly seen IDEM tumors are schwannomas, neurofibromas, and meningiomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Tumor
- What is being tested?
- surgical excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Dec 2022to May 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with intradural extramedullary lesion in dorsolumber region
Who cannot join
- previous history of spinal surgery
- unfit medical patients
- multiple level affection
- associated cervical lesion
- unstable segment
Trial locations and contacts
1 site in 1 country.
mohammed M abd el-Aal, professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Magdy M Amin, professor
About this study
Primary spinal cord tumors constitute 2-4% of all central nervous system neoplasms; they are classfied as extradural, intradural extramedullary (IDEM: 65%), and intramedullary The most commonly seen IDEM tumors are schwannomas, neurofibromas, and meningiomas. [1] The less frequently encountered IDEM tumors include ependymomas, lipomas, hemangiomas, metastatic deposits, paragangliomas, nerve sheath myxomas, and vascular tumors.[2] Spinal cord tumors can cause different signs and symptoms, especially as tumors grow. The tumors may affect spinal cord or the nerve roots, blood vessels or bones of spine. Signs and symptoms may include: Pain at the site of the tumor due to tumor growth Back pain, often radiating to other parts of body Feeling less sensitive to pain, heat and cold Loss of bowel or bladder function Difficulty walking, muscle weakness .
MRI is the investigation of choice,however other investigation such CT or X ray are important to ensure stability of the vertebral column and the optimal management is gross total excision for symptomatic lesions.[3,4] Over the years, there has been no significant change in the clinical symptoms and pathology of IDEM tumors. However, there have been dramatic improvements in the diagnosis and treatment with the advances of radiological and surgical techniques. Despite advances in operative techniques and neuroimaging, the morbidity associated with the resection of IDEM tumors continues to be significant [5,6].
Here, we examined the surgical outcomes of 20 patients with IDEM spinal cord tumors operated in Neurosurgery department at Sohag university Hospital
- Conditions
- Spinal Cord Tumor
- Being tested
- surgical excision
- 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.
surgical excisionProcedure or surgery
posterior midline approach and total excision for spinal cord tumors
| Study group | Role | What they receive |
|---|---|---|
| spinal cord tumors group | Experimental | Not described Receives: Procedure: surgical excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
american spinal injury association scale
grading of impairment for motor and sensory functions grade A for complete sensory and motor loss grade E for normal motor and sensory
Measured: 6 months
visual analogue pain scale
pain scale from zero to ten depend on severity of pain,
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start13 Dec 2022
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed AHmed Kassem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678608
- Sponsor's protocol ID
- soh-med-22-12-02
- Status last verified
- Dec 2022
- First submitted
- 19 Dec 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Song KW, Shin SI, Lee JY, Kim GL, Hyun YS, Park DY. Surgical results of intradural extramedullary tumors. Clin Orthop Surg. 2009 Jun;1(2):74-80. doi: 10.4055/cios.2009.1.2.74. Epub 2009 May 27.
PubMed 19885058Abul-Kasim K, Thurnher MM, McKeever P, Sundgren PC. Intradural spinal tumors: current classification and MRI features. Neuroradiology. 2008 Apr;50(4):301-14. doi: 10.1007/s00234-007-0345-7. Epub 2007 Dec 15.
PubMed 18084751Narayan S, Rege SV, Gupta R. Clinicopathological Study of Intradural Extramedullary Spinal Tumors and Its Correlation With Functional Outcome. Cureus. 2021 Jun 18;13(6):e15733. doi: 10.7759/cureus.15733. eCollection 2021 Jun.
PubMed 34285844
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcome of Dorsolumbar Intradural Extramedullary Spinal Cord Tumors
- ClinicalTrials.gov ID
- NCT05678608
- Acronym / sponsor ID
- soh-med-22-12-02
- Conditions
- Spinal Cord Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 10 Jan 2023 (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.
Primary spinal cord tumors constitute 2-4% of all central nervous system neoplasms; they are classfied as extradural, intradural extramedullary (IDEM: 65%), and intramedullary The most commonly seen IDEM tumors are schwannomas, neurofibromas, and meningiomas. [1] The less frequently encountered IDEM tumors include ependymomas, lipomas, hemangiomas, metastatic deposits, paragangliomas, nerve sheath myxomas, and vascular tumors.[2] Spinal cord tumors can cause different signs and symptoms, especially as tumors grow. The tumors may affect spinal cord or the nerve roots, blood vessels or bones of spine. Signs and symptoms may include: Pain at the site of the tumor due to tumor growth Back pain, often radiating to other parts of body Feeling less sensitive to pain, heat and cold Loss of bowel or bladder function Difficulty walking, muscle weakness .
MRI is the investigation of choice,however other investigation such CT or X ray are important to ensure stability of the vertebral column and the optimal management is gross total excision for symptomatic lesions.[3,4] Over the years, there has been no significant change in the clinical symptoms and pathology of IDEM tumors. However, there have been dramatic improvements in the diagnosis and treatment with the advances of radiological and surgical techniques. Despite advances in operative techniques and neuroimaging, the morbidity associated with the resection of IDEM tumors continues to be significant [5,6].
Here, we examined the surgical outcomes of 20 patients with IDEM spinal cord tumors operated in Neurosurgery department at Sohag university Hospital
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 group | Experimental | Procedure: surgical excision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with intradural extramedullary lesion in dorsolumber region
Key exclusion criteria (5 listed)
- previous history of spinal surgery
- unfit medical patients
- multiple level affection
- associated cervical lesion
- unstable segment
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 |
|---|---|---|
| surgical excisionposterior midline approach and total excision for spinal cord tumors | Procedure or surgery | spinal cord tumors group |
Primary outcome
american spinal injury association scale
Time frame: 6 months
grading of impairment for motor and sensory functions grade A for complete sensory and motor loss grade E for normal motor and sensory
visual analogue pain scale
Time frame: 6 months
pain scale from zero to ten depend on severity of pain,
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Background: PubMed 19885058Song KW, Shin SI, Lee JY, Kim GL, Hyun YS, Park DY. Surgical results of intradural extramedullary tumors. Clin Orthop Surg. 2009 Jun;1(2):74-80. doi: 10.4055/cios.2009.1.2.74. Epub 2009 May 27.
- Background: PubMed 18084751Abul-Kasim K, Thurnher MM, McKeever P, Sundgren PC. Intradural spinal tumors: current classification and MRI features. Neuroradiology. 2008 Apr;50(4):301-14. doi: 10.1007/s00234-007-0345-7. Epub 2007 Dec 15.
- Background: PubMed 34285844Narayan S, Rege SV, Gupta R. Clinicopathological Study of Intradural Extramedullary Spinal Tumors and Its Correlation With Functional Outcome. Cureus. 2021 Jun 18;13(6):e15733. doi: 10.7759/cureus.15733. eCollection 2021 Jun.
- Individual participant dataSharing planned: Yes
Related trials for Spinal Cord Tumor
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
RecruitingPhase 3
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)
Metastatic Castration Resistant Prostate Cancer
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 4
Remimazolam vs Propofol for Motor and Somatosensory Evoked Potentials in Spinal Tumor Surgery
Spinal Cord Neoplasms, Spinal Neoplasms
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.
mohammed M abd el-Aal, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgical excision in people with Spinal Cord Tumor, run by Sohag University at 1 site in Egypt.
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 5 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 10 Jan 2023. 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 Egypt. 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 mohamed M kassem, demonstrator (010980-03153, mohamed011152@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
american spinal injury association scale (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05678608, which also lists 3 linked publications.
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 10 Jan 2023.