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Identification of miRNAs Associated With Gender Difference in Osteoarthritis Patients (MIRGOA)

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ClinicalTrials.gov Identifier: NCT04851210
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : September 1, 2022
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

Brief Summary:
The biological study involves the collection of samples from male and female patients (intraoperative waste tissue, blood and synovial fluid), suffering from mild and moderate-severe OA, who undergo endo or arthro-prosthesis surgery, or arthroplasty, for the identification and characterization of a panel of "gender-specific" miRNAs. MicroRNAs will be extracted from the samples (chondrocytes, synoviocytes, osteoblasts and plasma) and will be molecularly characterized in order to identify a panel of miRNAs differently expressed according to the gender and severity of OA. The lymphocyte and phenotypically and functionally characterized populations will be isolated from the corpuscular component and the synovial fluid, in order to evaluate a possible gender-specific difference in the progression of OA-dependent inflammation.

Condition or disease Intervention/treatment
Osteoarthritis Other: No intervention

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of miRNAs Associated With Gender Difference in Osteoarthritis Patients
Actual Study Start Date : March 21, 2022
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis


Intervention Details:
  • Other: No intervention
    No intervention


Primary Outcome Measures :
  1. Change assessment of OA 'gender-specific miRNA panel during time [ Time Frame: Time points: 24 hours; 72 hours; 1 month ]

    Identification and characterization of a 'gender-specific' miRNA panel related to disease progression in patients with mild OA (OA with Kellgren Lawrence-KL grade I and II) and moderate-severe (OA with greater or greater KL score equal to grade III).

    The miRNAs will be isolated from patients affected by OA who undergo endo- or arthro-prosthesis operations starting: 1) from cells isolated from waste tissues; and 2) from the plasma taken 24 hours before surgery, and subsequently at 72 hours and 1 month from this.



Secondary Outcome Measures :
  1. Functional role of OA 'gender-specific' miRNAs [ Time Frame: 2 months ]
    Define the functional role (regulated or modulated signaling) of each deregulated (up or down-regulated) miRNA through specific in vitro studies.

  2. Change assessment of OA 'gender-specific' inflammatory response during time [ Time Frame: Time points: 24 hours; 72 hours; 1 month ]
    Characterize any differences in the inflammatory response (release of cytokines and inflammatory factors) based on the patient's gender and the severity of the disease, analyzing the lymphocyte component isolated from the blood sample performed 24h before and 72h and 1 month after surgery and analyzing the liquid synovial isolated in the operative site.

  3. OA 'gender-specific' miRNAs as biomarkers of osteointegration [ Time Frame: 12 months ]
    Define some miRNAs (modulated in the same way at the tissue and circulating level) that can be used as "gender-specific" predictive biomarkers of the efficiency of the osteointegrative capacity in the patient with OA.


Biospecimen Retention:   Samples With DNA
Blood and synovial fluid specimen, surgical waste joint tissues (bone, sinovia, cartilage)


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A maximum number of n = 20 patients with clinical and radiological diagnosis of OA will be enrolled: n = 10 with OA defined as "moderate-severe" equivalent to the KL score greater than or equal to grade III (n = 5 males and n = 5 females); and n = 10 with OA defined as "mild" equivalent to the grade I and II KL score (n = 5 males and n = 5 females), who undergo endo or arthro-prosthesis surgery, or arthroscopy. All patients will be enrolled in the clinical trial only after having personally dated and signed the written informed consent.
Criteria

Inclusion Criteria:

  • Patients of both sexes suffering from OA in hospital for the surgical treatment of OA (endo- or arthroplasty, or arthroscopy) with an interval of at least three months from any previous infiltrative treatment of any kind;
  • Patients with a Kellgren and Lawrence (KL) [Kohn 2016] score greater than or equal to grade III will be enrolled in the 'Moderate-severe OA' group and those with grade I and II KL scores in the 'MIld OA' group;
  • Patients able to provide the list of medications and supplements taken;
  • Patients able to provide informed consent to treatment.

Exclusion Criteria:

  • Patients who have undergone previous joint surgery or who have excessive joint deformity.
  • Patients with recent trauma, osteonecrosis or OA induced by previous or current joint infection;
  • Patients with metabolic pathologies;
  • Patients with previous or current oncological pathologies;
  • Women in a climacteric (date of last menstruation less than one year);
  • Patients with severe cognitive deficits or psychiatric disorders;
  • Autoimmune diseases (eg rheumatoid arthritis).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851210


Contacts
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Contact: Gianluca Giavaresi, MD +39 3774548728 gianluca.giavaresi@ior.it
Contact: Viviana Costa, B.Sc Ph.D viviana.costa@ior.it

Locations
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Italy
Dipartimento Rizzoli Sicilia - Istituto Ortopedico Rizzoli Recruiting
Bagheria, Palermo, Italy, 90011
Contact: Giovanni Pignatti, MD    +39 091 9297 069    giovanni.pignatti@ior.it   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
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Principal Investigator: Viviana Costa, B.Sc Ph.D IRCCS Istituto Ortopedico Rizzoli
Publications:

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Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT04851210    
Other Study ID Numbers: 148/2021/Sper/IOR
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: September 1, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto Ortopedico Rizzoli:
miRNA
osteoarthritis
gender
biomarker
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases