UNderstanding the Causes Of Idiopathic Scoliosis Through the Longitudinal Analysis of Proteomic Markers: the UNCOIL Study

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07634627
Status
Recruiting
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Conditions

  • Adolescent Idiopathic Scoliosis (AIS)
  • Neuromuscular Scoliosis

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Accepted

Study Details

The goal of this observational study is to find clinical, demographic, and protein biomarkers that scoliosis progression (scoliosis curve increases) and/or differ between participants with scoliosis versus those without scoliosis. We aim to answer the following questions: 1. Are age, sex, skeletal maturity, and family history associated with scoliosis curve progression? 2. Do protein levels differ between progressive and non-progressive cases? 3. Do protein levels change between baseline and follow-up visits in progressive and non-progressive scoliosis cases? 4. Do proteins differ between participants with AIS vs those without AIS? 5. Do proteins or change in proteins differ between participants with AIS vs those with scoliosis secondary to neuromuscular conditions. Participants will: * Participate in two research visits 6-12 months apart at a Children's Hospital Colorado location. * Participate in a blood draw at each study visit to collect about 3 tablespoons of blood. * Fill out surveys yearly regarding new medical visits, pain, physical function, anxiety and depression, medical and family history, and current medications.

Key Dates

Start date
Dec 5, 2024
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2031

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Scoliosis cases
    Participants with clinician diagnosed adolescent idiopathic scoliosis, defined as Cobb angle \>=10 degrees with rotation.
  • Arm: Controls
    Participants without adolescent idiopathic scoliosis, described as a spinal curvature (Cobb angle) of \<10 degrees.
  • Arm: Neuromuscular scoliosis
    Participants with physician confirmed scoliosis, defined as Cobb angle \>=10 degrees, secondary to a neuromuscular condition.

Primary Outcome Measure

Change in curve severity [ Time Frame: Baseline and 6-12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital Colorado AnschutzAuroraColorado80045-

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado Anschutz· Aurora, CO

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