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CompletedNCT03164070Updated Jan 9, 2019

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

An observational study in Osteoarthritis, sponsored by The Republican Research and Practical Center for Epidemiology and Microbiology. Completed at 1 site in Belarus. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-01-09.

Sponsored by The Republican Research and Practical Center for Epidemiology and Microbiology · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
121
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study evaluates laboratory-based method to estimate the degrees of activity of medium and large joint osteoarthritis.

Read the 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.

02

Conditions studied

  • Osteoarthritis

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Keywords

  • Osteoarthritis
  • Flow cytometry
  • Synovial fluid
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with medium and large joint osteoarthritis

Inclusion criteria

  • medium and large joint active osteoarthritis

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
121 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Patients with osteoarthritis

    Patients with medium and large joint osteoarthritis

  • Control group

    Control group of healthy persons

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What researchers measure

Primary outcomes

  1. The sensitivity of the proposed laboratory-based method in the diagnostics of the activity of osteoarthritis

    The sensitivity of the proposed laboratory-based method in the diagnostics of the activity of medium and large joint osteoarthritis

    Time frame: 2 month

06

Study locations

1 site
  • Andrei Hancharou
    Minsk, 220114, Belarus
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03164070
Lead sponsor
The Republican Research and Practical Center for Epidemiology and Microbiology
Collaborators
Belarusian Medical Academy of Post-Graduate Education
Responsible party
Andrei Y. Hancharou (Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology) — Principal investigator
First posted
May 23, 2017
Start date
Jul 1, 2016
Primary completion
Dec 10, 2018
Completion
Dec 29, 2018
Last update
Jan 9, 2019

Study contacts

Andrei Y Hancharou, Dr
study director · Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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