NCT02315729

Brief Summary

The purpose of this study is to identify potential markers for curve progression in adolescent idiopathic scoliosis (AIS). Despite its prevalence and impact on child health, the etiology of AIS and molecular mechanisms underlying its development and progression remain poorly understood. Clinical criteria and features cannot adequately predict which children, diagnosed with mild disease, will undergo subsequent curve progression requiring intervention. The investigators hypothesize that alterations in specific genetic markers will be correlated with the progression of AIS curves over time. Thus, these markers could be used in the future to develop a reliable, inexpensive and relatively non-invasive cell based diagnostic test to (1) predict spinal curve progression in AIS, (2) select patients likely to benefit from early surgical intervention, and (3) potentially screen for asymptomatic children at risk of developing idiopathic scoliosis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Nov 2016Dec 2028

First Submitted

Initial submission to the registry

December 3, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 12, 2014

Completed
1.9 years until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Expected
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

9.1 years

First QC Date

December 3, 2014

Last Update Submit

September 26, 2023

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

  • Scoliosis Curve Progression

    Cobb angle, disc wedging, vertebral body wedging, coronal balance, sagittal balance

    3 years

Eligibility Criteria

Age10 Years - 13 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Female patients with adolescent idiopathic scoliosis

You may qualify if:

  • Females aged 10-13 years
  • Diagnosed with mild-moderate spine deformity (Cobb angle 15-30 degrees)

You may not qualify if:

  • Patients with scoliosis other than idiopathic
  • Trauma
  • Inflammatory disease
  • Malignancies
  • Diabetes
  • History of previous spine surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children'S Hospital of Colorado

Denver, Colorado, 80045, United States

RECRUITING

Study Officials

  • Evalina L Burger, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

jiandong hao

CONTACT

303-724-7457jiandong.hao@cuanschutz.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2014

First Posted

December 12, 2014

Study Start

November 1, 2016

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2028

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

US(1)