TumorNCT01105520
Neurologic and Neurophysiologic Assessment of Clinical Course in Patients With Intraspinal Processes
An observational study of Tumor, run by University of Zurich at 1 site in Switzerland.
Trial summary
Patients included in the study are treated at the Klinik für Neurochirurgie USZ. The clinical course is documented at Paraplegikerzentrum Balgrist using validated diagnostic procedures (e.g. SCIM, ASIA, neurophysiology). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor
- What is being tested?
- Diagnostic
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated surgically for intraspinal processes
Who may be able to join
- Benign intraspinal process (tumor or vascular malformation AVM)
- Primary lesion caudal of the brainstem, affecting C1
- Cognitive ability to give written informed consent
Who cannot join
- Metastases, malign tumors
- Traumatic lesions
- Myelitis, polyneuropathy
- Disc prolaps
Trial locations and contacts
1 site in 1 country.
01 Studienregister MasterAdmins contact
About this study
Patients included in the study are treated at the Klinik für Neurochirurgie USZ. The clinical course is documented at Paraplegikerzentrum Balgrist using validated diagnostic procedures (e.g. SCIM, ASIA, neurophysiology).
Study aims:
Prognostic value of clinical diagnosis and additional diagnostic procedures? Which parameters exhibit optimal prognostic power? Differences between tumor/AVM associated lesions and traumatic lesions? What can we learn for pathophysiology and treatment?
- Trial with surgical intervention
- Conditions
- Tumor
- Being tested
- Diagnostic
- Keywords
- Intraspinal processes (tumor or vascular malformation AVM)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnosticProcedure or surgery
SCIM Spinal Cord Independence Measure ASIA scale American Spinal Injury Association
| Study group | Role | What they receive |
|---|---|---|
| intralspinal processes | Patients with intralspinal processes Receives: Procedure: Diagnostic |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startJan 2010
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105520
- Sponsor's protocol ID
- ZU-XYZ-003
- Status last verified
- Apr 2010
- First submitted
- 15 Apr 2010
- Last updated
- 16 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurologic and Neurophysiologic Assessment of Clinical Course in Patients With Intraspinal Processes
- ClinicalTrials.gov ID
- NCT01105520
- Acronym / sponsor ID
- ZU-XYZ-003
- Conditions
- Tumor
- Keywords
- Intraspinal processes (tumor or vascular malformation AVM)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2010
- Study completion
- Dec 2015
- First posted
- 16 Apr 2010 (estimated)
- 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.
Patients included in the study are treated at the Klinik für Neurochirurgie USZ. The clinical course is documented at Paraplegikerzentrum Balgrist using validated diagnostic procedures (e.g. SCIM, ASIA, neurophysiology).
Study aims:
Prognostic value of clinical diagnosis and additional diagnostic procedures? Which parameters exhibit optimal prognostic power? Differences between tumor/AVM associated lesions and traumatic lesions? What can we learn for pathophysiology and treatment?
- Trial with surgical intervention
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intralspinal processes | – | Procedure: DiagnosticPatients with intralspinal processes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated surgically for intraspinal processes
Key inclusion criteria (3 listed)
- Benign intraspinal process (tumor or vascular malformation AVM)
- Primary lesion caudal of the brainstem, affecting C1
- Cognitive ability to give written informed consent
Key exclusion criteria (4 listed)
- Metastases, malign tumors
- Traumatic lesions
- Myelitis, polyneuropathy
- Disc prolaps
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 |
|---|---|---|
| DiagnosticSCIM Spinal Cord Independence Measure ASIA scale American Spinal Injury Association | Procedure or surgery | intralspinal processes |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2010.
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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.
01 Studienregister MasterAdmins contact
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
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 Tumor, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 4 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 16 Apr 2010. 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 Switzerland. 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 01 Studienregister MasterAdmins (+41 (0)44 255 11 11), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 16 Apr 2010.