UNderstanding the Causes Of Idiopathic Scoliosis Through... | NCT07634627

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

NCT07634627

Sponsor

University of Colorado, Denver

Status

Recruiting

Last Update Posted

Jun 23, 2026Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Adolescent Idiopathic Scoliosis (AIS)
Neuromuscular Scoliosis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2024Actual

Primary Completion Date

Dec 2029Estimated

Completion Date

Dec 2031Estimated

First Submitted Date

Jun 4, 2026

First Submission Date that Met QC Criteria

Jun 4, 2026

First Posted Date

Jun 9, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2026

Last Update Posted Date

Jun 23, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	6 to 12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

17 Years

Standard Ages

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Siera R Rossi, B.S.	Contact	720-777-1050		siera.rossi@cuanschutz.edu
Patrick Carry, PhD	Contact			patrick.carry@cuanschutz.edu

Overall Officials

Name	Affiliation	Role
Patrick Carry, PhD	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital Colorado Anschutz	Recruiting	Aurora	Colorado	80045	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided