- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01813916
Identification and Characterization of the Biomarker in Synovial Fluid for Hyaluronic Acid Therapy in Osteoarthritis
March 14, 2013 updated by: National Taiwan University Hospital
The purpose of this study is to use the proteomic analysis of synovial fluid to perform the comprehensive investigation of the biomarker that will be useful to assign the tratment effectiveness of five weekly intra-articular HA injection.
Study Overview
Detailed Description
The intra-articular injection with HA is an accepted therapy for OA.
However, the exact regulation of HA treatment is unclear.
Compared the expression SF proteome from OA patients who received HA/800 treatment or not (post and pre-HA treatment) may be possible to identify the protein that response to the HA treatment and apply this to prognosis of OA.
We used two-dimensional difference gel electrophoresis (2D-DIGE) combined with matrix-assisted laser desorption ionization time of light mass spectrometry (MALDI-TOF) to determine the differentially displayed proteins in human SF.
Finally, we used Western blotting and ELISA analysis to validate the potential biomarkers.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei city, Taiwan
- Ccj@Ntu.Edu.Tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of osteoarthritis
- Accept the intra-articular HA injection therapy
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: proteomic analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To study the protein expression of synovial fluid for hyaluronic acid therapy in osteoarthritis
Time Frame: up to 12 months
|
We used two-dimensional difference gel electrophoresis (2D-DIGE) combined with matrix-assisted laser desorption ionization time of light mass spectrometry (MALDI-TOF) to determine the differentially displayed proteins in human synovial fluid.
|
up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
January 30, 2013
First Submitted That Met QC Criteria
March 14, 2013
First Posted (Estimate)
March 19, 2013
Study Record Updates
Last Update Posted (Estimate)
March 19, 2013
Last Update Submitted That Met QC Criteria
March 14, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200804039R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.