NCT01951365

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 1998

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
13.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 26, 2013

Completed
Last Updated

September 26, 2013

Status Verified

September 1, 2013

Enrollment Period

13.7 years

First QC Date

September 15, 2013

Last Update Submit

September 23, 2013

Conditions

SchwannomaNeurinoma

Keywords

SchwannomaGrowthintraduralnatural history

Outcome Measures

Primary Outcomes (1)

  • Volumetric growth rate

    12, 24, 36, 48, 72, 96,120,144 months

Study Arms (2)

Growing schwannoma

Overall volumetric growth rate more over than 10%

Stable schwannoma

Overall volumetric growth rate less than 10%

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients diagnosed of spinal IDEM schwannoma in 2 institutes

You may qualify if:

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

You may not qualify if:

  • \) surgical resection at the diagnosis; 2) von Recklinghausen' disease (neurofibromatosis); and 3) recurred or residual tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam, Kyenggi, 110-769, South Korea

Location

Seoul Natl. Univ. Hospital

Seoul, 110-769, South Korea

Location

Biospecimen

Retention: NONE RETAINED

The investigators analyzed MR images only

MeSH Terms

Conditions

Neurilemmoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeuromaNerve Sheath NeoplasmsNeoplasms, Nerve Tissue

Study Officials

  • Chang-Hyun Lee, MD

    Seoul Natl. Univ. Bundang Hospital

    PRINCIPAL INVESTIGATOR

  • Chun Kee Chung, MD, PhD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 15, 2013

First Posted

September 26, 2013

Study Start

June 1, 1998

Primary Completion

February 1, 2012

Study Completion

August 1, 2013

Last Updated

September 26, 2013

Record last verified: 2013-09

Locations

KR(2)