- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02315729
Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis
The purpose of this study is to identify potential markers for curve progression in adolescent idiopathic scoliosis (AIS). Despite its prevalence and impact on child health, the etiology of AIS and molecular mechanisms underlying its development and progression remain poorly understood. Clinical criteria and features cannot adequately predict which children, diagnosed with mild disease, will undergo subsequent curve progression requiring intervention.
The investigators hypothesize that alterations in specific genetic markers will be correlated with the progression of AIS curves over time. Thus, these markers could be used in the future to develop a reliable, inexpensive and relatively non-invasive cell based diagnostic test to (1) predict spinal curve progression in AIS, (2) select patients likely to benefit from early surgical intervention, and (3) potentially screen for asymptomatic children at risk of developing idiopathic scoliosis.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jiandong Hao
- Phone Number: 303-724-7457
- Email: Jiandong.Hao@cuanschutz.edu
Study Locations
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-
Colorado
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Denver, Colorado, United States, 80045
- Recruiting
- Children's Hospital of Colorado
-
Contact:
- Jiandong Hao
- Phone Number: 303-724-7457
- Email: Jiandong.Hao@cuanschutz.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Females aged 10-13 years
- Diagnosed with mild-moderate spine deformity (Cobb angle 15-30 degrees)
Exclusion Criteria:
- Patients with scoliosis other than idiopathic
- Trauma
- Inflammatory disease
- Malignancies
- Diabetes
- History of previous spine surgery
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scoliosis Curve Progression
Time Frame: 3 years
|
Cobb angle, disc wedging, vertebral body wedging, coronal balance, sagittal balance
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Evalina L Burger, MD, University of Colorado - Anschutz Medical Campus
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-0884
- UL1TR001082 (U.S. NIH Grant/Contract)
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.
Clinical Trials on Adolescent Idiopathic Scoliosis
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