CompletedNot Applicable

Identification of Circulating microRNAs in Adolescent Idiopathic Scoliosis

Italy30 participantsStarted 2020-07-22

Plain-language 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.

Who can participate

Age range

11 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Isolation of circulating microRNAs from AIS patients and healthy controls

Timeframe: Within 24 hours of blood sampling

Expression profiling of circulating microRNAs from AIS patients and healthy controls

Timeframe: Within 2 months of blood sampling

Trial details

NCT IDNCT04746586

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-08-31

View on ClinicalTrials.gov More Adolescent Idiopathic Scoliosis trials