NCT02934594

Brief Summary

Patients with metastatic spinal cord compression (MSCC) are treated with different options according to the life expectancy. Survival and surgical outcome can be influenced by surgical timing in MSCC patients treated with palliative decompression.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

Status
unknown

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

October 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

October 17, 2016

Status Verified

October 1, 2016

Enrollment Period

3.8 years

First QC Date

October 11, 2016

Last Update Submit

October 13, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • survival rate

    5 years

Study Arms (3)

Group A

Motor function intact group: received palliative decompression

Other: Palliative Decompression

Group B1

motor deficit group: received palliative decompression within 48 hours after symptoms occured

Other: Palliative Decompression

Group B2

motor deficit group: received palliative decompression 48 hours after symptoms occured

Other: Palliative Decompression

Interventions

palliative decompression to MSCC patients: before motor deficit (Group A), within 48 hours after motor deficit (Group B1), 48 hours after motor deficit (Group B2)

Group AGroup B1Group B2

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression.

You may qualify if:

  • Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression in National Taiwan University Hospital after January 1st, 2012.

You may not qualify if:

  • Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression before December 31st, 2011, or those who were not treated in National Taiwan University Hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Tokuhashi Y, Matsuzaki H, Oda H, Oshima M, Ryu J. A revised scoring system for preoperative evaluation of metastatic spine tumor prognosis. Spine (Phila Pa 1976). 2005 Oct 1;30(19):2186-91. doi: 10.1097/01.brs.0000180401.06919.a5.

    PMID: 16205345BACKGROUND
  • Tomita K, Kawahara N, Kobayashi T, Yoshida A, Murakami H, Akamaru T. Surgical strategy for spinal metastases. Spine (Phila Pa 1976). 2001 Feb 1;26(3):298-306. doi: 10.1097/00007632-200102010-00016.

    PMID: 11224867BACKGROUND

MeSH Terms

Conditions

Neoplasm MetastasisSpinal Cord Compression

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord InjuriesWounds and Injuries

Study Officials

  • Shu-Hua Yang, M.D., Ph.D.

    National Taiwan University Hospital

    STUDY CHAIR

Central Study Contacts

Shu-Hua Yang, M.D., Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2016

First Posted

October 17, 2016

Study Start

October 1, 2016

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

October 17, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share