NCT07634627 · University of Colorado, Denver
UNderstanding the Causes Of Idiopathic Scoliosis Through the Longitudinal Analysis of Proteomic Markers: the UNCOIL Study
(UNCOIL)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Aurora, Colorado
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 23, 2026 · Source of record for eligibility and locations