- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02722681
Developing a Biomarker for Monitoring Clinical Outcomes in Children With Spinal Lipoma.
Developing a Biomarker for Monitoring Clinical Outcomes in Children With Spinal Lipoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Clinical study to seek a metabolic biomarker(s), detectable by mass spectrometry, that can be used to 'stratify' patients with asymptomatic lipoma. In view of the often extensive nature of lipomas associated with the low spinal cord, we hypothesise that lipid components, or metabolites derived from them, may gain entry to the child's bloodstream. The more infiltrative lipomas carry a higher risk of symptomatic deterioration and, we argue, should also have a higher chance of generating a lipid 'signature' in the blood and/or urine. Phase 1 - Cerebrospinal fluid, blood and urine samples will be obtained from patients with spinal lipoma undergoing surgery (n = 3 to 5). Informed consent, following appropriate ethics committee approval, will be implemented. Blood and urine will be sampled pre-operatively, and intra-operative cerebrospinal fluid samples will be obtained. Mass spectrometry analysis will identify lipid species present in the cerebrospinal fluid of these patients, and the extent to which these are also detectable in the patient's blood and/or urine. Any lipid species detected in both cerebrospinal fluid and blood/urine will represent potential biomarkers, and will form the focus of the next phase of the study. Phase 2 will then assess the discriminatory value of these potential biomarkers by comparing their profiles in blood and/or urine from three clinical groups: (i) Patients with spinal lipomas who have neurological symptoms/signs, and are attending hospital for surgery (i.e. similar patients as in Phase 1). Blood/urine samples will be taken preoperatively, to represent the 'high risk' group. (ii) Patients with spinal lipomas who have remained asymptomatic after several years follow-up.
These represent the 'low risk' group; (iii) Patients with spinal conditions not involving lipoma. These represent our 'negative' control group. Group sizes will be determined by power calculations using variance data from the patient measurements in Phase 1. Statistical analysis will be by 1-way ANOVA, or non-parametric equivalent, to test for significant differences between the three groups. Mass spectrometry (Figure 2) will be performed in the Institute of Child Health Centre for Proteomics, Metabolomics and Lipidomics using nano ultra performance liquid chromatography and ultra performance convergence chromatography - quadrupole time of flight mass spectrometry, a new mass spectral technology for lipidomic and metabolomic analysis. Ultra performance convergence chromatography is a chromatography technology that uses carbon dioxide present in a super critical fluid state as a mobile phase and allows the fractionation of metabolites and lipids according to their class and not hydrophobicity. It enables quantitation of all the major lipid classes present in a tissue including phospholipids, free fatty acids, esterified fatty acids, cholesterol esters and sterols. Non-lipid molecules (e.g. choline) might also show altered abundance in lipoma patients and so a more general metabolomics analysis will also be undertaken, if time permits.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
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London, United Kingdom, WC1N1EH
- Recruiting
- Institute of Child Health
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Contact:
- Victoria Jones
- Phone Number: 02072429789
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patient with proven spinal lipoma
Exclusion Criteria:
- complex spinal lipomas related to other developmental abnormalities
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Collection of blood and urine samples taken during usual clinical management
Collection of cerebrospinal fluid samples taken during usual clinical management
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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.
|
Collection of blood and urine samples taken during usual clinical management
|
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.
|
Collection of blood and urine samples taken during usual clinical management
Collection of cerebrospinal fluid samples taken during usual clinical management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lipid signature within blood or urine samples of patients with symptomatic spinal lipomas
Time Frame: 2 years
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Andrew Copp, PhD, Institute of Child Health, UCL
- Study Director: Dominic Thompson, FRCS, Great Ormond Street Hospital NHS Trust
- Study Director: Kevin Mills, PhD, Institute of Child Health, UCL
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13ND18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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