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Assessment of Volumetric Growth Rates of Spinal Intradural Extramedullary Schwannoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01951365
First Posted: September 26, 2013
Last Update Posted: September 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chang-Hyun Lee, Seoul National University Hospital
  Purpose

Spinal intradural schwannoma detected incidentally increased recently. Because there is little knowledge about natural history of spinal schwannoma, there is no consensus of treatment. Our hypothesis is as follows;

  1. Some schwannomas keep growing, the others do not.
  2. Foraminal schwannomas do not usually grow.

The investigators analyzed natural history and characteristics of 56 spinal schwannomas observed initially with accurate and reliable methods. Here the investigators displayed growing pattern and differential point of spinal schwannoma.


Condition
Schwannoma Neurinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Assessment of Volumetric Growth Rates of Spinal Intradural Extramedullary Schwannoma: A Longitudinal Study of Natural History

Resource links provided by NLM:


Further study details as provided by Chang-Hyun Lee, Seoul National University Hospital:

Primary Outcome Measures:
  • Volumetric growth rate [ Time Frame: 12, 24, 36, 48, 72, 96,120,144 months ]

Biospecimen Retention:   None Retained
The investigators analyzed MR images only

Enrollment: 56
Study Start Date: June 1998
Study Completion Date: August 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Growing schwannoma
Overall volumetric growth rate more over than 10%
Stable schwannoma
Overall volumetric growth rate less than 10%

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients diagnosed of spinal IDEM schwannoma in 2 institutes
Criteria

Inclusion Criteria:

  • All patients who were diagnosed of spinal IDEM schwannoma by MR imaging and checked follow-up MR imaging not undergoing surgical resection (including radiosurgery).

Exclusion Criteria:

  • 1) surgical resection at the diagnosis; 2) von Recklinghausen' disease (neurofibromatosis); and 3) recurred or residual tumor.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951365


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Kyenggi, Korea, Republic of, 110-769
Seoul Natl. Univ. Hospital
Seoul, Korea, Republic of, 110-769
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Chang-Hyun Lee, MD Seoul Natl. Univ. Bundang Hospital
Study Chair: Chun Kee Chung, MD, PhD Seoul National University Hospital
  More Information

Responsible Party: Chang-Hyun Lee, Clinical Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01951365     History of Changes
Other Study ID Numbers: SNUNS-spine-01
First Submitted: September 15, 2013
First Posted: September 26, 2013
Last Update Posted: September 26, 2013
Last Verified: September 2013

Keywords provided by Chang-Hyun Lee, Seoul National University Hospital:
Schwannoma
Growth
intradural
natural history

Additional relevant MeSH terms:
Neurilemmoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neuroma
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue