Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04746586
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2020-11-26
Brief Title:
Identification of Circulating microRNAs in Adolescent Idiopathic Scoliosis
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Istituto Ortopedico Rizzoli
Study Overview
Official Title:
Identification and Characterization of Circulating microRNAs as Diagnostic Biomarkers in Adolescent Idiopathic Scoliosis
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMIRSA
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 andor 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
Detailed Description:
MATERIALS AND METHODS 1 Collection of a venous blood sample from patients enrolled with AIS or controls and subsequent separation of plasma 2 Isolation of circulating total RNA from the plasma of AIS patients Kit Invitrogen Total RNA Isolation Reagent and preparation of microRNA samples TaqMan MicroRNA Reverse Transcription Kit 3 Analysis of microRNA expression profiles by micro-array technique Taqman Advanced miRNAs Human CardA B 4 Validation of deregulated microRNAs by single-qRT-PCR assay and computational functional analyses and 5 In vitro studies to investigate the molecular role of the microRNAs identified within the mechanisms of bone remodeling
Enrollment Procedures
Patients considered eligible will be enrolled in the study after providing a written informed consent Healthy subjects control group will be recruited on a voluntary basis by means of an announcement published on the web page of the Rizzoli Orthopedic Institute wwwiorit News section
Data Collection Clinical data will be retrieved by patients source document A protocol-specific CRF reporting the results of the analyses will be provided A CRF is required and should be completed for each included subject
Ethics The clinical trial protocol and its documents will be sent before initiating the study to the competent Authorities and Ethics Committees of each participating country for its approval The responsible investigator will ensure that this study is conducted in agreement with either the most updated Declaration of Helsinki and all the international and local laws that apply to clinical trials and to patient protection The protocol has been written and the study will be conducted according to the principles of the ICH Harmonized Tripartite Guideline for Good Clinical Practice ref httpwwwemeaeuintpdfshumanich013595enpdf
Informed Consent All patients will be informed by the investigator of the aims of the study the possible risks and benefits that will derive from the study participation The Investigator must clearly inform that the patient is free to refuse participation in the study and that can withdraw consent at any time and for any reason The patients will be informed as to the strict confidentiality of their personal data but the medical records of the patients enrolled may be reviewed for trial purposes by authorized individuals other than their treating physician The informed consent procedure must conform to the ICH guidelines on Good Clinical Practice This implies that the written informed consent form should be signed and personally dated by the patient or by the patients legally acceptable representative
The Investigator must also sign the Informed Consent form and will keep the original at the site and a copy of the original must be handed to the patient
The competent ethics committee for each Institution participating to the study must validate local informed consent documents before the study can be opened It will be emphasized that the participation is voluntary and that the patient is allowed to refuse further participation in the study whenever heshe wants This will not prejudice the patients subsequent care
General Principles for Human Biological Material HBM collection Human biological material HBM collection involves the collection and storage of biological material residual biological material or derivatives in compliance with ethical and technical requirements Biological material blood samples will be centralized and stored at Istituto Ortopedico Rizzoli - Dipartimento Rizzoli-Sicilia Bagheria Palermo From here the biological material will be used and stored according with the sample characteristic and applicable regulation
Plasma and circulating total RNA obtained from blood will be stored inside sterile containers falcon tubes eppendorf in a freezer at the temperature of -80 C at the Istituto Ortopedico Rizzoli - Dipartimento Rizzoli Sicilia
The following principles apply to storage of HBM a The Istituto Ortopedico Rizzoli will have a designated person responsible for collection and will act as a communication point b The collected HBM should be documented ie the amount remaining and its location act as a communication point and c The storage and use of biological material will take place in accordance with the standards of good laboratory practice GLP and applicable legislation
Confidentiality In order to ensure confidentiality of clinical trial data as disposed the national and European applicable regulation data will be only accessible for the trial Sponsor and its designees for monitoringauditing procedures the Investigator and collaborators the Ethics Committee of each corresponding site and the Health Authority Investigator and the Institution will allow access to data and source documentation for monitoring auditing Ethic Committee revision and inspections of Health Authority but maintaining at all times subject personal data confidentiality as specified in the applicable regulation
The Investigator must guarantee that patient anonymity is kept at all times and their identity must be protected from unauthorized persons and institutions
All patients included in the study will be identified with a numeric code so that no identifiable personal data will be collected The Investigator must have and conserve a patients inclusion registry where it figures the personal data of the patient name surname address and corresponding identification code into the study this register will be kept on the Investigator File
Publication policy and data ownership The principal investigator of the study is responsible for the final report of the publication publish all the data collected as described in the protocol and will ensure that the data are reported responsibly and consistently In particular the publication of data deriving from the present study will take place independently of the results obtained The transmission or dissemination of data through scientific publications and or presentation at conferences congresses and seminars will take place exclusively following the purely statistical processing of the same or in an absolutely anonymous form All the study data are owned by the sponsor
Enrollment Procedures
Patients considered eligible will be enrolled in the study after providing a written informed consent Healthy subjects control group will be recruited on a voluntary basis by means of an announcement published on the web page of the Rizzoli Orthopedic Institute wwwiorit News section
Data Collection Clinical data will be retrieved by patients source document A protocol-specific CRF reporting the results of the analyses will be provided A CRF is required and should be completed for each included subject
Ethics The clinical trial protocol and its documents will be sent before initiating the study to the competent Authorities and Ethics Committees of each participating country for its approval The responsible investigator will ensure that this study is conducted in agreement with either the most updated Declaration of Helsinki and all the international and local laws that apply to clinical trials and to patient protection The protocol has been written and the study will be conducted according to the principles of the ICH Harmonized Tripartite Guideline for Good Clinical Practice ref httpwwwemeaeuintpdfshumanich013595enpdf
Informed Consent All patients will be informed by the investigator of the aims of the study the possible risks and benefits that will derive from the study participation The Investigator must clearly inform that the patient is free to refuse participation in the study and that can withdraw consent at any time and for any reason The patients will be informed as to the strict confidentiality of their personal data but the medical records of the patients enrolled may be reviewed for trial purposes by authorized individuals other than their treating physician The informed consent procedure must conform to the ICH guidelines on Good Clinical Practice This implies that the written informed consent form should be signed and personally dated by the patient or by the patients legally acceptable representative
The Investigator must also sign the Informed Consent form and will keep the original at the site and a copy of the original must be handed to the patient
The competent ethics committee for each Institution participating to the study must validate local informed consent documents before the study can be opened It will be emphasized that the participation is voluntary and that the patient is allowed to refuse further participation in the study whenever heshe wants This will not prejudice the patients subsequent care
General Principles for Human Biological Material HBM collection Human biological material HBM collection involves the collection and storage of biological material residual biological material or derivatives in compliance with ethical and technical requirements Biological material blood samples will be centralized and stored at Istituto Ortopedico Rizzoli - Dipartimento Rizzoli-Sicilia Bagheria Palermo From here the biological material will be used and stored according with the sample characteristic and applicable regulation
Plasma and circulating total RNA obtained from blood will be stored inside sterile containers falcon tubes eppendorf in a freezer at the temperature of -80 C at the Istituto Ortopedico Rizzoli - Dipartimento Rizzoli Sicilia
The following principles apply to storage of HBM a The Istituto Ortopedico Rizzoli will have a designated person responsible for collection and will act as a communication point b The collected HBM should be documented ie the amount remaining and its location act as a communication point and c The storage and use of biological material will take place in accordance with the standards of good laboratory practice GLP and applicable legislation
Confidentiality In order to ensure confidentiality of clinical trial data as disposed the national and European applicable regulation data will be only accessible for the trial Sponsor and its designees for monitoringauditing procedures the Investigator and collaborators the Ethics Committee of each corresponding site and the Health Authority Investigator and the Institution will allow access to data and source documentation for monitoring auditing Ethic Committee revision and inspections of Health Authority but maintaining at all times subject personal data confidentiality as specified in the applicable regulation
The Investigator must guarantee that patient anonymity is kept at all times and their identity must be protected from unauthorized persons and institutions
All patients included in the study will be identified with a numeric code so that no identifiable personal data will be collected The Investigator must have and conserve a patients inclusion registry where it figures the personal data of the patient name surname address and corresponding identification code into the study this register will be kept on the Investigator File
Publication policy and data ownership The principal investigator of the study is responsible for the final report of the publication publish all the data collected as described in the protocol and will ensure that the data are reported responsibly and consistently In particular the publication of data deriving from the present study will take place independently of the results obtained The transmission or dissemination of data through scientific publications and or presentation at conferences congresses and seminars will take place exclusively following the purely statistical processing of the same or in an absolutely anonymous form All the study data are owned by the sponsor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None