NCT07634627 UNderstanding the Causes Of Idiopathic Scoliosis Through the Longitudinal Analysis of Proteomic Markers: the UNCOIL Study
| NCT ID | NCT07634627 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Adolescent Idiopathic Scoliosis (AIS) |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-12-05 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2024-12-05 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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: 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.
Eligibility Criteria
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
Contact & Investigator
Patrick Carry, PhD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT07634627 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 17 Years, studying Adolescent Idiopathic Scoliosis (AIS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07634627 currently recruiting?
Yes, NCT07634627 is actively recruiting participants. Contact the research team at siera.rossi@cuanschutz.edu for enrollment information.
Where is the NCT07634627 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT07634627 clinical trial?
NCT07634627 is sponsored by University of Colorado, Denver. The principal investigator is Patrick Carry, PhD at University of Colorado, Denver. The trial plans to enroll 500 participants.