NCT02315729 Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis
| NCT ID | NCT02315729 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Adolescent Idiopathic Scoliosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 380 participants |
| Start Date | 2016-11 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 380 participants in total. It began in 2016-11 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Evalina L Burger, MD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT02315729 clinical trial?
This trial is open to female participants only, aged 10 Years or older, up to 13 Years, studying Adolescent Idiopathic Scoliosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02315729 currently recruiting?
Yes, NCT02315729 is actively recruiting participants. Contact the research team at jiandong.hao@cuanschutz.edu for enrollment information.
Where is the NCT02315729 trial being conducted?
This trial is being conducted at Denver, United States.
Who is sponsoring the NCT02315729 clinical trial?
NCT02315729 is sponsored by University of Colorado, Denver. The principal investigator is Evalina L Burger, MD at University of Colorado, Denver. The trial plans to enroll 380 participants.