OsteoarthritisNCT03164070
Study of the Laboratory-based Evaluation of the Degrees of Activity of Osteoarthritis
An observational study of Osteoarthritis, run by The Republican Research and Practical Center for Epidemiology and Microbiology at 1 site in Belarus.
Trial summary
This study evaluates laboratory-based method to estimate the degrees of activity of medium and large joint osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis
- How many people
- 121 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jul 2016to 29 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with medium and large joint osteoarthritis
Who may be able to join
- medium and large joint active osteoarthritis
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Laboratory-based Evaluation of the Degrees of Activity of Medium and Large Joint Osteoarthritis
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.
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Flow cytometry, Synovial fluid
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with osteoarthritis | Patients with medium and large joint osteoarthritis | |
| Control group | Control group of healthy persons |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start1 Jul 2016
- Primary completion10 Dec 2018
- Study completion29 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Republican Research and Practical Center for Epidemiology and Microbiology
- Sponsor type
- University, hospital or other
- Collaborators
- Belarusian Medical Academy of Post-Graduate Education
- Responsible party
- Principal investigator, Andrei Y. Hancharou, The Republican Research and Practical Center for Epidemiology and Microbiology
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164070
- Sponsor's protocol ID
- RRPCEM_OA
- Status last verified
- Jan 2019
- First submitted
- 22 May 2017
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Laboratory-based Evaluation of the Degrees of Activity of Medium and Large Joint Osteoarthritis
- ClinicalTrials.gov ID
- NCT03164070
- Acronym / sponsor ID
- RRPCEM_OA
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Flow cytometry, Synovial fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- The Republican Research and Practical Center for Epidemiology and MicrobiologyUniversity, hospital or other
- Collaborators
- Belarusian Medical Academy of Post-Graduate Education
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 29 Dec 2018 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates laboratory-based method to estimate the degrees of activity of 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with osteoarthritis | – | –Patients with medium and large joint osteoarthritis |
| Control group | – | –Control group of healthy persons |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with medium and large joint osteoarthritis
Key inclusion criteria (1 listed)
- medium and large joint active osteoarthritis
Key exclusion criteria (8 listed)
- refuse of patient to participate in the trial;
- acute infectious diseases;
- pregnancy/lactation;
- intercurrent severe chronic diseases;
- HIV, Hepatites B/C;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, run by The Republican Research and Practical Center for Epidemiology and Microbiology at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity of the proposed laboratory-based method in the diagnostics of the activity of osteoarthritis (time frame: 2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.