RecruitingNot Applicable

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

United States500 participantsStarted 2024-12-05

Plain-language 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.

Who can participate

Age range

10 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in curve severity

Timeframe: Baseline and 6-12 months

Curve progression

Timeframe: 6 to 12 months

Trial details

NCT IDNCT07634627

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-12

Contact for this trial

Siera R Rossi, B.S.

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

View on ClinicalTrials.gov More Adolescent Idiopathic Scoliosis (AIS) trials