NCT01643174

Brief Summary

Within defined groups of primary malignant and benign bone and soft tissue spine tumors, what variables (clinical, diagnostic, therapeutic, and/or demographic) are associated with overall survival?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

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

February 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2013

Enrollment Period

11 months

First QC Date

April 17, 2012

Last Update Submit

June 19, 2013

Conditions

Spine Tumor

Outcome Measures

Primary Outcomes (1)

  • overall survival

    Average of 10 years

Secondary Outcomes (1)

  • local recurrence

    Average of 10 years

Study Arms (1)

Surgical treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Retrospective chart review and selection

You may qualify if:

  • Were admitted to one of the participating spine centers with a diagnosis of primary tumor of the spine and were treated surgically.
  • At least one follow-up detectable in the medical charts

You may not qualify if:

  • metastatic tumor of the spine
  • primary spinal cord tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles Fisher

Vancouver, Canada

Location

Related Publications (2)

  • Disch AC, Boriani S, Luzzati A, Rhines LD, Fisher CG, Lazary A, Gokaslan ZL, Chou D, Clarke MJ, Fehlings MG, Schaser KD, Germscheid NM, Reynolds JJ, The Ao Spine Knowledge Forum Tumor. Extradural Primary Malignant Spinal Tumors in a Population Younger than 25 Years: An Ambispective International Multicenter Study on Onco-Surgical Outcomes. Cancers (Basel). 2023 Jan 30;15(3):845. doi: 10.3390/cancers15030845.

    PMID: 36765803DERIVED

  • Fisher CG, Goldschlager T, Boriani S, Varga PP, Rhines LD, Fehlings MG, Luzzati A, Dekutoski MB, Reynolds JJ, Chou D, Berven SH, Williams RP, Quraishi NA, Bettegowda C, Gokaslan ZL. An evidence-based medicine model for rare and often neglected neoplastic conditions. J Neurosurg Spine. 2014 Nov;21(5):704-10. doi: 10.3171/2014.7.SPINE13954. Epub 2014 Sep 5.

    PMID: 25192373DERIVED

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2012

First Posted

July 18, 2012

Study Start

February 1, 2012

Primary Completion

January 1, 2013

Study Completion

May 1, 2013

Last Updated

June 20, 2013

Record last verified: 2013-06

Locations

CA(1)