Neurologic and Neurophysiologic Assessment of Clinical Co... | NCT01105520

Studies
Neurologic and Neurophysiologic Assessment of Clinical Course in Patients With Intraspinal Processes

NCT01105520

Sponsor

University of Zurich

Status

Unknown status

Last Update Posted

Apr 16, 2010Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Tumor

Interventions

Diagnostic

Countries

Switzerland

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

Apr 2010

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

Jan 2010

Primary Completion Date

Not provided

Completion Date

Dec 2015

First Submitted Date

Apr 15, 2010

First Submission Date that Met QC Criteria

Apr 15, 2010

First Posted Date

Apr 16, 2010Estimated

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

Apr 15, 2010

Last Update Posted Date

Apr 16, 2010Estimated

Description Module

Brief 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).

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

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

Not provided

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intralspinal processes		Patients with intralspinal processes	Procedure: Diagnostic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diagnostic	Procedure	SCIM Spinal Cord Independence Measure ASIA scale American Spinal Injury Association	intralspinal processes

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Benign intraspinal process (tumor or vascular malformation AVM)
Primary lesion caudal of the brainstem, affecting C1
Cognitive ability to give written informed consent

Exclusion criteria:

Metastases, malign tumors
Traumatic lesions
Myelitis, polyneuropathy
Disc prolaps

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients treated surgically for intraspinal processes

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
01 Studienregister MasterAdmins	Contact	+41 (0)44 255 11 11

Overall Officials

Name	Affiliation	Role
01 Studienregister MasterAdmins	UniversitaetsSpital Zuerich	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
	Recruiting	Zurich			Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided