Adolescent Idiopathic Scoliosis (AIS)UNCOILNCT07634627
UNderstanding the Causes Of Idiopathic Scoliosis Through the Longitudinal Analysis of Proteomic Markers: the UNCOIL Study
An observational study of Adolescent Idiopathic Scoliosis (AIS) and Neuromuscular Scoliosis, run by University of Colorado, Denver at 1 site in United States.
Trial 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: 1. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS), Neuromuscular Scoliosis
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2024to Dec 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Patrick Carry, PhD contact
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado Anschutz
Aurora, Colorado, 80045
About this 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:
- Are age, sex, skeletal maturity, and family history associated with scoliosis curve progression?
- Do protein levels differ between progressive and non-progressive cases?
- Do protein levels change between baseline and follow-up visits in progressive and non-progressive scoliosis cases?
- Do proteins differ between participants with AIS vs those without AIS?
- Do proteins or change in proteins differ between participants with AIS vs those with scoliosis secondary to neuromuscular conditions.
Read more
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.
- Keywords
- Adolescent Idiopathic Scoliosis, Proteomics, AIS, Idiopathic Scoliosis, protein biomarkers, biomarkers, plasma proteomics, Neuromuscular scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start5 Dec 2024
- Primary completionDec 2029 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Carry, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634627
- Sponsor's protocol ID
- 24-0316
- Acronym
- UNCOIL
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to collection of genetics and sensitive medical data, the investigators 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.