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

NCT07634627 | Recruiting

• 1 other identifier: 24-0316
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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. The investigators aim to answer the following questions:

• 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.

Conditions

Adolescent Idiopathic Scoliosis (AIS); Neuromuscular Scoliosis

Keywords

Adolescent Idiopathic Scoliosis; Proteomics; AIS; Idiopathic Scoliosis; protein biomarkers; biomarkers; plasma proteomics; Neuromuscular scoliosis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado Anschutz

Aurora, Colorado, 80045, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and/or sputum will be collected, processed, and stored. DNA and RNA will be retained from both samples. Plasma and serum from blood will also be retained for protein quantification.

Study Officials

• Patrick Carry, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siera R Rossi, B.S.

CONTACT

720-777-1050; siera.rossi@cuanschutz.edu

Patrick Carry, PhD

CONTACT

patrick.carry@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 9, 2026
• Study Start: December 5, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2031
• Last Updated: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)