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Study of the Laboratory-based Evaluation of the Degrees of Activity of Osteoarthritis

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03164070
First Posted: May 23, 2017
Last Update Posted: May 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Belarusian Medical Academy of Post-Graduate Education
Information provided by (Responsible Party):
Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology
  Purpose
This study evaluates laboratory-based method to estimate the degrees of activity of medium and large joint osteoarthritis.

Condition
Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Laboratory-based Evaluation of the Degrees of Activity of Medium and Large Joint Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology:

Primary Outcome Measures:
  • The sensitivity of the proposed laboratory-based method in the diagnostics of the activity of osteoarthritis [ Time Frame: 2 month ]
    The sensitivity of the proposed laboratory-based method in the diagnostics of the activity of medium and large joint osteoarthritis


Biospecimen Retention:   Samples Without DNA
Synovial fluid samples stored in the tube with sodium heparin. Venous blood samples drained into tube with sodium heparin.

Estimated Enrollment: 70
Actual Study Start Date: July 1, 2016
Estimated Study Completion Date: December 31, 2019
Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with osteoarthritis
Patients with medium and large joint osteoarthritis

Detailed Description:
Osteoarthritis (OA) is a chronic progressive disease, characterized by degradation of joint cartilage, synovial inflammation and joint dysfunction. This study evaluates laboratory-based method to estimate the degrees of activity of medium and large joint OA. Samples of synovial fluid (SF) from the patients with the OA (ICD-10 codes: M15, M16 and M17) will be assessed for T-cell subsets, msast cells, fibroblast-like synoviocytes (FLS) and macrophage-like synoviocytes (MLS) by flow cytometry. Subpopulations of blood T-cells involved in the inflammation will also be assayed. Standard clinical investigation will be performed and the results will be used to estimate the laboratory criteria or degrees of activity of medium and large joint OA.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with medium and large joint osteoarthritis
Criteria

Inclusion Criteria:

  • medium and large joint active osteoarthritis

Exclusion Criteria:

  • refuse of patient to participate in the trial;
  • acute infectious diseases;
  • pregnancy/lactation;
  • intercurrent severe chronic diseases;
  • HIV, Hepatites B/C;
  • active tuberculosis;
  • alcohol use disorder/drug addiction;
  • malignant neoplasms/leukemia.
  Contacts and Locations
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): NCT03164070


Locations
Belarus
Andrei Hancharou
Minsk, Belarus, 220114
Sponsors and Collaborators
The Republican Research and Practical Center for Epidemiology and Microbiology
Belarusian Medical Academy of Post-Graduate Education
Investigators
Study Director: Andrei Y Hancharou, Dr Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
  More Information

Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
In Russian
Study Protocol  This link exits the ClinicalTrials.gov site
Brief study protocol (algorithm) in Russian

Responsible Party: Andrei Y. Hancharou, Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology
ClinicalTrials.gov Identifier: NCT03164070     History of Changes
Other Study ID Numbers: RRPCEM_OA
First Submitted: May 22, 2017
First Posted: May 23, 2017
Last Update Posted: May 24, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology:
Osteoarthritis
Flow cytometry
Synovial fluid

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases