Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis

NCT ID: NCT02315729

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adolescent Idiopathic Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with scoliosis other than idiopathic
* Trauma
* Inflammatory disease
* Malignancies
* Diabetes
* History of previous spine surgery
Minimum Eligible Age

10 Years

Maximum Eligible Age

13 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Evalina L Burger, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Children'S Hospital of Colorado

Denver, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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jiandong hao

Role: CONTACT

303-724-7457

Facility Contacts

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jiandong hao

Role: primary

303-724-7457

Other Identifiers

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UL1TR001082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-0884

Identifier Type: -

Identifier Source: org_study_id

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