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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-17
SponsorUniversity of Colorado, Denver

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 3 trial groups
Group A: Scoliosis cases
Group B: Controls
Group C: Neuromuscular scoliosis

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 6-12 months
2

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.

Time frame
6 to 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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