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

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.

Study Overview

• Status: Recruiting
• Conditions: Adolescent Idiopathic Scoliosis (AIS); Neuromuscular Scoliosis

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Siera R Rossi, B.S.; Phone Number: 720-777-1050; Email: siera.rossi@cuanschutz.edu
• Study Contact Backup: Name: Patrick Carry, PhD; Email: patrick.carry@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado Anschutz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Scoliosis patients will be recruited from a Children's Hospital Colorado spine clinic during a routine visit for their scoliosis. Controls will be recruited from a Children's Hospital Colorado spine clinic for those who were suspected to have scoliosis with spinal curvature <10 degrees, or from a Children's Hospital Colorado sports clinic seen for a musculoskeletal injury or condition.

Description

Inclusion Criteria:

• Patients 10-17 years old with idiopathic or neuromuscular scoliosis with a cobb angle of 10-50°

Exclusion Criteria:

• Children diagnosed with certain genetic conditions that affect the bones or muscles (Turner syndrome, down syndrome, Marfan syndrome, osteogenesis imperfecta, muscular dystrophy, Ehlers-Danlos syndrome, VATER/VACTERL syndrome, Rett syndrome, Prader Willi syndrome, or Angelman syndrome)
• Patients with congenital scoliosis, early onset scoliosis (diagnosed before 9 years old), or those who have spine surgery scheduled prior to the first study visit
• Patients whose spinal curve is >50 degrees
• Those taking medications that may influence protein expression (baclofen, prednisone/corticosteroids, antiepileptic medications, diazepam, tizanidine, and/or dantrolene)
• Patients who are pregnant
• Patients with neurocognitive disorders who are non-verbal and/or non-ambulatory

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in curve severity	The change in Cobb angle of the primary scoliosis curve between the baseline and the 6-12 month visit will be quantified.	Baseline and 6-12 months
Curve progression	Curve progression will be defined as an increase in Cobb angle between the baseline and 6-12 month follow-up visit of >=6 degrees and/or need for spine surgery or other invasive surgical intervention.	6 to 12 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Patrick Carry, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: June 4, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: biomarkers; Proteomics; Adolescent Idiopathic Scoliosis; AIS; Idiopathic Scoliosis; Neuromuscular scoliosis; protein biomarkers; plasma proteomics
• Other Study ID Numbers: 24-0316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to collection of genetics and sensitive medical data, we do not plan on sharing individual level data with other researchers at this time. While there is no current plan to share IPD, data may be made available in the future if required by funding agencies or sponsoring organizations, and in accordance with applicable regulations, institutional policies, and participant consent. Any data shared will be de-identified to protect participant privacy and confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No