An Exploratory Clinical Study to Investigate Biomarkers of Senescence in Patients With Osteoarthritis of the Knee
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|ClinicalTrials.gov Identifier: NCT03100799|
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : August 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Procedure: Arthroscopy Procedure: Arthrocentesis Diagnostic Test: MRI||Not Applicable|
This is an exploratory non-drug, interventional, hypothesis generating biomarker study. No Investigational Product will be administered in the study, however, there are study related procedures which are interventional such as arthroscopy, arthrocentesis and infusion of a gadolinium-containing contrast agent.
Consented patients who meet the selection criteria undergo MRI imaging with and without gadolinium contrast of both knees. Approximately seven days following the MRI imaging, patients undergo an arthrocentesis of both knees to obtain synovial fluid and then an arthroscopy of the target knee to obtain synovial and non-weight bearing cartilage tissues.
The patient will return to the clinic approximately seven days following the arthroscopy and arthrocentesis procedures for a routine safety follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm, exploratory non-drug, interventional biomarker study in patients with active osteoarthritis to investigate the degree of senescence-associated disease|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||An Exploratory Clinical Study to Investigate Biomarkers of Senescence in Patients With Mild, Moderate and Severe Osteoarthritis of the Knee|
|Actual Study Start Date :||March 2, 2017|
|Actual Primary Completion Date :||July 10, 2017|
|Actual Study Completion Date :||July 10, 2017|
Patients with osteoarthritis of the knee
This is an exploratory non-drug, interventional biomarker study, however, there are study related procedures which are interventional such as arthroscopy, arthrocentesis and MRI assessment with infusion of a gadolinium-contrast agent.
Arthroscopy of the target knee
Arthrocentesis of the target knee and contralateral knee (if patient consents)
Diagnostic Test: MRI
MRI with and without a gadolinium-based contrast agent
Other Name: Magnetic resonance imaging
- Degree of synovial senescence as defined by the percentage of cells staining positive for candidate molecular markers of senescence on IHC in patients with osteoarthritis [ Time Frame: Study Visit 3 (Day 14) ]Percentage of cells staining positive for candidate molecular markers of senescence on IHC
- Concentration of candidate biomarkers in serum, plasma, and urine and correlate with concentration in synovial fluid include but not limited to p16, p21, IL6 [ Time Frame: Screening (Day 1) and Visit 3 (Day 14) ]Correlation between candidate biomarkers in serum or plasma and urine with synovial fluid biomarkers
- Correlation between senescence burden in synovial tissue (percentage of cells staining positive om IHC) and synovitis (semi-quantitative scoring of synovium by gadolinium-enhanced MRI) [ Time Frame: Visit 2 (Day 7) and Visit 3 (Day 14) ]Relationship between the synovial senescence, synovitis via biopsy samples and synovitis using gadolinium-enhanced MRI
- Inter-interval variability of candidate biomarkers of senescence [ Time Frame: Screening (Day 1) and Visit 3 (Day 14) ]Inter-interval variability of candidate biomarkers of senescence
- Correlation between degree of synovitis (semi-quantitative scoring of synovium by gadolinium-enhanced MRI) with concentration of biomarkers in plasma or synovial fluid [ Time Frame: Screening (Day 1), Visit 2 (Day 7) and Visit 3 (Day 14) ]To determine the relationship between GE-MRI-based assessment of synovium and plasma or synovial candidate biomarkers
- Correlation between senescence burden (percentage of cells staining positive on IHC) and phenotypic disease data (e.g., Kellgren Lawrence score) in patients with osteoarthritis [ Time Frame: Screening (Day 1), Visit 2 (Day 7) and Visit 3 (Day 14) ]To explore the possible relationships between the degree of synovial senescence and other biomarkers that are identified as potentially relevant in patients with osteoarthritis
- Correlation between synovitis (semi-quantitative scoring of synovium by gadolinium-enhanced MRI) and pain (WOMAC-A as derived from KOOS Knee Survey) [ Time Frame: Screening (Day 1), Visit 2 (Day 7) and Visit 3 (Day 14) ]To explore the relationship of synovitis defined by either GE-MRI or by histologic assessment of synovial biopsy samples with WOMAC-A (as derived from the KOOS Knee Survey)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100799
|United States, Maryland|
|The Arthritis Treatment Center|
|Frederick, Maryland, United States, 21702|
|Principal Investigator:||Nathan Wei, MD||The Arthritis Treatment Center|