Actively Recruiting

Age: 11Years - 17Years
All Genders
Healthy Volunteers
ID04746586

Identification and Characterization of Circulating microRNAs as Diagnostic Biomarkers in Adolescent Idiopathic Scoliosis

Led by Istituto Ortopedico Rizzoli · Updated on 2025-01-27

30

Participants Needed

1

Research Sites

282 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the expression of a wide range of microRNAs in the blood plasma of patients with Adolescent Idiopathic Scoliosis (AIS). These microRNAs have been previously studied in other orthopedic conditions and bone metabolism. The study aims to identify deregulated microRNAs in AIS patients, validate them, and explore their potential role in bone and cartilage tissue metabolism. The goal is to develop a microRNA panel to help diagnose and predict the progression of AIS based on molecular data. Participants will have a blood sample collected to separate plasma, from which circulating total RNA will be isolated. MicroRNA samples will be prepared and analyzed using micro-array techniques, followed by validation through single-qRT-PCR assays and computational analyses. Further in vitro studies will investigate how identified microRNAs influence bone remodeling processes. Healthy volunteers will also be recruited as controls to compare with AIS patients. During the study, clinical data from participants will be collected and matched with microRNA results. Blood samples and RNA will be securely stored at a dedicated center at -80°C. Researchers will measure microRNA profiles and expression levels within specified timeframes after blood sampling. Data confidentiality and participant anonymity will be strictly maintained. The study includes informed consent procedures and will follow ethical standards and good clinical practice guidelines throughout the research process.

CONDITIONS

Official Title

Identification of Circulating microRNAs in Adolescent Idiopathic Scoliosis

Who Can Participate

Age: 11Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 11 and 17 years
  • Diagnosis of idiopathic scoliosis with a Cobb angle greater than 10 degrees
  • Minimum follow-up of two years
  • Clinical data and radiological tests available
  • No surgical treatment prior to enrollment
  • Healthy subjects aged 11 to 17 years without orthopedic or oncological diseases (controls)
Not Eligible

You will not qualify if you...

  • Severe cognitive impairment or psychiatric disorders
  • Scoliosis due to secondary causes
  • Women of childbearing age who are pregnant

AI-Screening

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Trial Site Locations

Total: 1 location

1

Dipartimento Rizzoli-Sicilia

Bagheria, Italy, 90011

Actively Recruiting

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Research Team

G

Gianluca Giavaresi, MD

L

Lavinia Raimondi, BSc PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth.

Stefano Negrini, Sabrina Donzelli, Angelo Gabriele Aulisa...

https://pubmed.ncbi.nlm.nih.gov/29435499

Identification of Competing Endogenous RNA Regulatory Networks in Vitamin A Deficiency-Induced Congenital Scoliosis by Transcriptome Sequencing Analysis.

Chong Chen, Haining Tan, Jiaqi Bi...

https://pubmed.ncbi.nlm.nih.gov/30110682