Identifying microRNAs in adolescents with scoliosis
Identification and Characterization of Circulating microRNAs as Diagnostic Biomarkers in Adolescent Idiopathic Scoliosis
Istituto Ortopedico Rizzoli · NCT04746586
This study is trying to find specific microRNAs in the blood of teenagers with scoliosis to see if they can help in diagnosing and understanding the condition better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 11 Years to 17 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Locations | 1 site (Bagheria) |
| Trial ID | NCT04746586 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the expression of various microRNAs in the plasma of patients with Adolescent Idiopathic Scoliosis (AIS). It involves collecting blood samples from AIS patients and healthy controls, isolating circulating RNA, and analyzing microRNA expression profiles using advanced techniques. The study seeks to identify deregulated microRNAs and their potential role in bone and cartilage metabolism, ultimately developing a diagnostic and prognostic tool for AIS. The findings will be validated in a larger population to enhance understanding of AIS at a molecular level.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 11-17 diagnosed with idiopathic scoliosis and a Cobb angle greater than 10 degrees.
Not a fit: Patients with scoliosis due to secondary causes or those with severe cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and prognostic tools for Adolescent Idiopathic Scoliosis.
How similar studies have performed: While the approach of using microRNAs as biomarkers is gaining traction, this specific application in AIS is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Cases: * Age between 11-17 years * Diagnosis of idiopathic scoliosis with a Cobb angle\> 10 ° * Minimum follow-up of two years * Clinical data and radiological tests available and no surgical treatment prior to enrollment in the study Controls: * Age between 11-17 years * Healthy subjects not affected by orthopedic and oncological diseases Exclusion Criteria: * Severe cognitive impairment or psychiatric disorders * Patients with scoliosis due to secondary causes * Women of childbearing age must not be pregnant
Where this trial is running
Bagheria
- Dipartimento Rizzoli-Sicilia — Bagheria, Italy (RECRUITING)
Study contacts
- Principal investigator: Angelo Toscano, MD — Istituto Ortopedico Rizzoli
- Study coordinator: Gianluca Giavaresi, MD
- Email: gianluca.giavaresi@ior.it
- Phone: +39 051 6366730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adolescent Idiopathic Scoliosis, Circulating microRNAs, Biomarkers