Study of the Laboratory-based Evaluation of the Degrees o... | NCT03164070

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

NCT03164070

Sponsor

The Republican Research and Practical Center for Epidemiology and Microbiology

Status

Completed

Last Update Posted

Jan 9, 2019Actual

Enrollment

121Actual

Phase

Not provided

Conditions

Osteoarthritis

Interventions

Not provided

Countries

Belarus

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2016Actual

Primary Completion Date

Dec 10, 2018Actual

Completion Date

Dec 29, 2018Actual

First Submitted Date

May 22, 2017

First Submission Date that Met QC Criteria

May 22, 2017

First Posted Date

May 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2019

Last Update Posted Date

Jan 9, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrei Y. Hancharou, Head of the Laboratory for Immunology and Cellular Biotechnology, The Republican Research and Practical Center for Epidemiology and MicrobiologyPrincipal Investigator

Lead Sponsor

The Republican Research and Practical Center for Epidemiology and MicrobiologyOTHER

Collaborators

Name	Class
Belarusian Medical Academy of Post-Graduate Education	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

121Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with osteoarthritis		Patients with medium and large joint osteoarthritis
Control group		Control group of healthy persons

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with medium and large joint osteoarthritis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Andrei Hancharou		Minsk		220114	Belarus

ID	Type	URL	Comment
	Informed Consent Form	View IPD

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided