Identification of Circulating microRNAs in Adolescent Idiopathic Scoliosis

NCT04746586 | Recruiting DMC

• 1 other identifier: IDCE-AVEC 575-2020-Sper-IOR
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to evaluate the expression of a large panel of microRNAs, already known and validated in other ortopedic pathologies and bone metabolism, in the plasma of Adolescent Idiopathic Scoliosis (AIS) patients. The deregulated microRNAs identified will be then validated and computational analyzes will determine their potential involvement in the metabolism of bone and/or cartilage tissue in order to correlate the results obtained with the clinical data of the AIS patients. The investigators aimed to develop a microRNAs panel to further validate in a larger population of AIS patients in order to produce a device for the diagnosis and prognosis of Molecular-based AIS.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Circulating microRNAs; Adolescent Idiopathic Scoliosis; Biomarkers

Outcome Measures

Primary Outcomes (2)

• Isolation of circulating microRNAs from AIS patients and healthy controls

  Plasma samples will be obtained from blood samples of 20 AIS patients and 10 healthy subjects, collected in commercially available anticoagulant-treated tubes and centrifuged for 15 minutes at 2,000 x g. Circulating microRNAs will be isolated from the plasma samples by using commercially available miRNA Plasma Purification kit, specifically designed for purify high-quality microRNAs from plasma samples. Quantification and quality control of the purified circulating microRNAs will be determined through micro-spectrophotometry and microfluidics-based platforms.

  Within 24 hours of blood sampling

• Expression profiling of circulating microRNAs from AIS patients and healthy controls

  The differentially expressed circulating microRNAs between AIS patients and healthy controls will be screened through micro-array technology using commercially available custom array microRNA cards, developed for profiling hundreds of unique human mature microRNAs known to be present in serum/plasma samples.

  Within 2 months of blood sampling

Secondary Outcomes (2)

• Bioinformatics analysis of circulating microRNAs in AIS patients and healthy controls.

  Within 3 months of blood sampling

• Functional role of the circulating microRNAs related to AIS

  Within 6 months of blood sampling

Study Arms (2)

Cases

20 patients with adolescent idiopathic scoliosis in a ratio of 5:1 between females and males will be enrolled.

Other: Circulating MiRNA indentification

Controls

10 healthy controls, of which 5 females and 5 males will be enrolled.

Other: Circulating MiRNA indentification

Interventions

Circulating MiRNA indentification OTHER

Identification of circulating miRNA useful to discriminate between worsening and stable forms of AIS

Cases; Controls

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

A maximum number of 20 AIS patients in a ratio of 5:1 between females and males is expected to be enrolled; 10 healthy controls, of which 5 females and 5 males will be enrolled. Patients and control group (healthy volunteers) will be enrolled in the clinical trial only after providing written informed consent.

You may qualify if:

• 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

You may not qualify if:

• Severe cognitive impairment or psychiatric disorders
• Patients with scoliosis due to secondary causes
• Women of childbearing age must not be pregnant

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Dipartimento Rizzoli-Sicilia

Bagheria, 90011, Italy

RECRUITING

Related Publications (10)

• Julien C, Gorman KF, Akoume MY, Moreau A. Towards a comprehensive diagnostic assay for scoliosis. Per Med. 2013 Jan;10(1):97-103. doi: 10.2217/pme.12.117.

  PMID: 29783473 RESULT

• Negrini S, Donzelli S, Aulisa AG, Czaprowski D, Schreiber S, de Mauroy JC, Diers H, Grivas TB, Knott P, Kotwicki T, Lebel A, Marti C, Maruyama T, O'Brien J, Price N, Parent E, Rigo M, Romano M, Stikeleather L, Wynne J, Zaina F. 2016 SOSORT guidelines: orthopaedic and rehabilitation treatment of idiopathic scoliosis during growth. Scoliosis Spinal Disord. 2018 Jan 10;13:3. doi: 10.1186/s13013-017-0145-8. eCollection 2018.

  PMID: 29435499 RESULT

• Giampietro PF. Genetic aspects of congenital and idiopathic scoliosis. Scientifica (Cairo). 2012;2012:152365. doi: 10.6064/2012/152365. Epub 2012 Dec 31.

  PMID: 24278672 RESULT

• Asher MA, Burton DC. Adolescent idiopathic scoliosis: natural history and long term treatment effects. Scoliosis. 2006 Mar 31;1(1):2. doi: 10.1186/1748-7161-1-2.

  PMID: 16759428 RESULT

• Kaelin AJ. Adolescent idiopathic scoliosis: indications for bracing and conservative treatments. Ann Transl Med. 2020 Jan;8(2):28. doi: 10.21037/atm.2019.09.69.

  PMID: 32055619 RESULT

• Li Z, Yu X, Shen J. Environmental aspects of congenital scoliosis. Environ Sci Pollut Res Int. 2015 Apr;22(8):5751-5. doi: 10.1007/s11356-015-4144-0. Epub 2015 Jan 29.

  PMID: 25628116 RESULT

• Sparrow DB, Chapman G, Smith AJ, Mattar MZ, Major JA, O'Reilly VC, Saga Y, Zackai EH, Dormans JP, Alman BA, McGregor L, Kageyama R, Kusumi K, Dunwoodie SL. A mechanism for gene-environment interaction in the etiology of congenital scoliosis. Cell. 2012 Apr 13;149(2):295-306. doi: 10.1016/j.cell.2012.02.054. Epub 2012 Apr 5.

  PMID: 22484060 RESULT

• Li Z, Li X, Shen J, Zhang L, Chan MTV, Wu WKK. Emerging roles of non-coding RNAs in scoliosis. Cell Prolif. 2020 Feb;53(2):e12736. doi: 10.1111/cpr.12736. Epub 2019 Dec 12.

  PMID: 31828859 RESULT

• Chen C, Tan H, Bi J, Li Z, Rong T, Lin Y, Sun L, Li X, Shen J. Identification of Competing Endogenous RNA Regulatory Networks in Vitamin A Deficiency-Induced Congenital Scoliosis by Transcriptome Sequencing Analysis. Cell Physiol Biochem. 2018;48(5):2134-2146. doi: 10.1159/000492556. Epub 2018 Aug 15.

  PMID: 30110682 RESULT

• Garcia-Gimenez JL, Rubio-Belmar PA, Peiro-Chova L, Hervas D, Gonzalez-Rodriguez D, Ibanez-Cabellos JS, Bas-Hermida P, Mena-Molla S, Garcia-Lopez EM, Pallardo FV, Bas T. Circulating miRNAs as diagnostic biomarkers for adolescent idiopathic scoliosis. Sci Rep. 2018 Feb 8;8(1):2646. doi: 10.1038/s41598-018-21146-x.

  PMID: 29422531 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and circulating total RNA obtained from whole blood of enrolled AIS patients and control group

Study Officials

• Angelo Toscano, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianluca Giavaresi, MD

CONTACT

+39 051 6366730; gianluca.giavaresi@ior.it

Lavinia Raimondi, BSc PhD

CONTACT

+39 327 3791290; lavinia.raimondi@ior.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: February 10, 2021
• Study Start: July 22, 2020
• Primary Completion: August 31, 2022
• Study Completion: December 21, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)