NCT02722681

Brief Summary

'Spinal lipoma' is a condition, present from before birth, in which fatty tissue (lipoma) is attached to the lower end of the spinal cord, tethering it within the vertebral canal. The cord normally moves up and down with respiration, whereas tethering prevents this movement, and can lead to progressive neurological deterioration. The cord and spinal nerves become stretched and their blood supply is damaged irreversibly. Disability may include weakness or pain in the lower body, and urinary disorders in young children. Treatment is surgical, to remove the lipoma and mobilise the spinal cord, with 60 such operations performed per year at Great Ormond Street Hospital. This project aims to develop lipidomic biomarkers in order to predict which children with spinal lipoma are at highest risk of neurological deterioration, and require early surgery, while providing evidence to adopt a more conservative approach for those at lower risk.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

2.8 years

First QC Date

March 16, 2016

Last Update Submit

March 23, 2016

Conditions

Lipoma of Spinal Cord

Outcome Measures

Primary Outcomes (1)

  • Lipid signature within blood or urine samples of patients with symptomatic spinal lipomas

    Lipid profiles from urine and blood samples from spinal lipoma patients will show specific lipids present at a higher concentration in symptomatic patients when compared with asymptomatic patients.

    2 years

Study Arms (3)

Symptomatic spinal lipoma patients

Spinal lipoma patients undergoing surgery due to symptomatic lipoma. Routine blood and urine samples will be taken pre-operatively, some will be kept aside for research. Cerebrospinal fluid is drained intraoperatively and usually discarded, some will be kept for research.

Procedure: Blood and urine samplingProcedure: Cerebrospinal fluid sampling

Asymptomatic spinal lipoma patients

Spinal lipoma patients who remain asymptomatic. Routine blood and urine samples will be taken as part of routine clinical care, some will be kept for research.

Procedure: Blood and urine sampling

Non-lipoma spinal conditions

Patients undergoing spinal surgery for a non-lipoma related condition. Routine blood and urine samples will be taken pre-operatively, some will be kept aside for research. Cerebrospinal fluid is drained intra-operatively and usually discarded, some will be kept for research.

Procedure: Blood and urine samplingProcedure: Cerebrospinal fluid sampling

Interventions

Blood and urine samplingPROCEDURE

Collection of blood and urine samples taken during usual clinical management

Asymptomatic spinal lipoma patientsNon-lipoma spinal conditionsSymptomatic spinal lipoma patients
Cerebrospinal fluid samplingPROCEDURE

Collection of cerebrospinal fluid samples taken during usual clinical management

Non-lipoma spinal conditionsSymptomatic spinal lipoma patients

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children under the age of 16 attending GOSH for management of spinal lipomas and non-lipoma related spinal conditions

You may qualify if:

  • patient with proven spinal lipoma

You may not qualify if:

  • complex spinal lipomas related to other developmental abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Child Health

London, WC1N1EH, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be stored during length of project.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Andrew Copp, PhD

    Institute of Child Health, UCL

    STUDY CHAIR

  • Dominic Thompson, FRCS

    Great Ormond Street Hospital NHS Trust

    STUDY DIRECTOR

  • Kevin Mills, PhD

    Institute of Child Health, UCL

    STUDY DIRECTOR

Central Study Contacts

Victoria Jones

CONTACT

02072429789

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2016

First Posted

March 30, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 30, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)