NCT05095142

Brief Summary

The purpose of this study is to identify genetic determinants of susceptibility to idiopathic osteoarthritis of the knee . It will assist in predicting individual risks of disease progression and would help to clarify pathophysiologic mechanisms of idiopathic osteoarthritis of the knee

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 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

First Submitted

Initial submission to the registry

October 21, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

March 30, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

October 21, 2021

Last Update Submit

March 13, 2023

Conditions

Keywords

SNP

Outcome Measures

Primary Outcomes (1)

  • enotyping for the SNP associated with liver cirrhosis

    Genotype frequency of SNP in the study genes of participants and control participants.

    1 year

Study Arms (2)

Experimental group:

patients with idiopathic osteoarthritis of the knee

Genetic: SNP analysis of the DNA

Control group

patients without idiopathic osteoarthritis of the knee

Genetic: SNP analysis of the DNA

Interventions

SNP analysis of the DNA obtained from peripheral blood sample

Control groupExperimental group:

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Persons of Kazakh nationality

You may qualify if:

  • Patients with bilateral idiopathic gonarthrosis aged 18 to 65 years;
  • Representatives of the Kazakh ethnic group up to the 3rd generation;
  • Hereditary history of arthrosis;
  • Persons who are able and willing to provide written informed consent;

You may not qualify if:

  • Patients with bilateral idiopathic gonarthrosis under 18 years of age and over 65 years of age;
  • Representatives of other ethnic groups;
  • Representatives of the Kazakh ethnic group less than 3 generations;
  • No family history of bilateral idiopathic gonarthrosis;
  • Patients with an acute period of the inflammatory process (laboratory and clinical signs);
  • Persons who, in the opinion of the researcher, are mentally or legally incapacitated, which prevents obtaining informed consent;
  • Pregnant or lactating women;
  • Tuberculosis of any localization in the active phase and in history;
  • Severe and decompensated diseases of the liver and kidneys, cardiovascular system;
  • Severe and decompensated course of endocrine diseases;
  • Autoimmune diseases;
  • Systemic diseases;
  • Oncological diseases;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scientific center of traumatology and orthopedics named after academician Batpenova ND

Almaty, Kazakhstan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

Study Officials

  • Olzhas Bekarisov, PhD

    Scientific center of traumatology and orthopedics named after academician Batpenova ND

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Laboratory of Experimental Medicine

Study Record Dates

First Submitted

October 21, 2021

First Posted

October 27, 2021

Study Start

March 30, 2022

Primary Completion

January 20, 2023

Study Completion

January 20, 2023

Last Updated

March 14, 2023

Record last verified: 2023-03

Locations