NCT03164070

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2018

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2018

Completed
Last Updated

January 9, 2019

Status Verified

January 1, 2019

Enrollment Period

2.4 years

First QC Date

May 22, 2017

Last Update Submit

January 7, 2019

Conditions

Osteoarthritis

Keywords

OsteoarthritisFlow cytometrySynovial fluid

Outcome Measures

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

    2 month

Study Arms (2)

Patients with osteoarthritis

Patients with medium and large joint osteoarthritis

Control group

Control group of healthy persons

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with medium and large joint osteoarthritis

You may qualify if:

  • medium and large joint active osteoarthritis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andrei Hancharou

Minsk, 220114, Belarus

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Synovial fluid samples stored in the tube with sodium heparin. Venous blood samples drained into tube with sodium heparin.

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Andrei Y Hancharou, Dr

    Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and Microbiology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Laboratory for Immunology and Cellular Biotechnology

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 23, 2017

Study Start

July 1, 2016

Primary Completion

December 10, 2018

Study Completion

December 29, 2018

Last Updated

January 9, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)