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Identification and Characterization of the Biomarker in Synovial Fluid for Hyaluronic Acid Therapy in Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
proteomic analysis
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoarthritis focused on measuring Osteoarthritis, synovial fluid, hyaluronic acid

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of osteoarthritis
  • Accept the intra-articular HA injection therapy

Exclusion Criteria:

-

Sites / Locations

  • Ccj@Ntu.Edu.Tw

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

proteomic analysis

Arm Description

Outcomes

Primary Outcome Measures

To study the protein expression of synovial fluid for hyaluronic acid therapy in osteoarthritis
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.

Secondary Outcome Measures

Full Information

First Posted
January 30, 2013
Last Updated
March 14, 2013
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01813916
Brief Title
Identification and Characterization of the Biomarker in Synovial Fluid for Hyaluronic Acid Therapy in Osteoarthritis
Official Title
Identification and Characterization of the Biomarker in Synovial Fluid for Hyaluronic Acid Therapy in Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, synovial fluid, hyaluronic acid

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
proteomic analysis
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
proteomic analysis
Primary Outcome Measure Information:
Title
To study the protein expression of synovial fluid for hyaluronic acid therapy in osteoarthritis
Description
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.
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of osteoarthritis Accept the intra-articular HA injection therapy Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Chuan Jiang, M.D.;Ph.D.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ccj@Ntu.Edu.Tw
City
Taipei city
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Identification and Characterization of the Biomarker in Synovial Fluid for Hyaluronic Acid Therapy in Osteoarthritis

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