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

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:

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.

Recruiting

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Key information

Conditions

Adolescent Idiopathic Scoliosis (AIS) Neuromuscular Scoliosis

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado Anschutz

Aurora, Colorado, 80045, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients 10-17 years old with idiopathic or neuromuscular scoliosis with a cobb angle of 10-50° that are currently being seen for their scoliosis at a Children's Hospital Colorado location

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
Patients who are not receiving care for scoliosis at a Children's Hospital Colorado location

Treatment and study plan

Primary outcomes

Change in curve severity

Time frame: Baseline and 6-12 months

The change in Cobb angle of the primary scoliosis curve between the baseline and the 6-12 month visit will be quantified.
Curve progression

Time frame: 6 to 12 months

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick Carry, PhD

CONTACT

[email protected]

Siera R Rossi, B.S.

CONTACT

[email protected]

720-777-1050

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Acronym: UNCOIL

Important dates

Study start: 2024
Primary completion: 2029
Study completion: 2031
First posted: Jun 9, 2026
Registry last updated: Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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