Genome-wide Study for Disease Susceptibility Gene(s) in Patients With Hand Osteoarthritis
1 other identifier
observational
100
1 country
1
Brief Summary
This is a case-control study involving one medical center and one research institute to develop a data-set containing a minimum of 100 osteoarthritis cases, minimum of 100 independent controls of similar gender ratio and a minimum of 100 disease controls (cases with hip and/or knee OA) to associate DNA sequence (allelic) variations in candidate genes with osteoarthritis phenotypes. This study is intended to begin at the Institute of Biomedical Sciences at Academia Sinica (which includes National Genotyping Center (NGC) and National Clinical Core (NCC)), National Taiwan University Hospital.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 5, 2013
CompletedFirst Posted
Study publicly available on registry
November 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedNovember 11, 2013
November 1, 2013
4.8 years
November 5, 2013
November 5, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Hand Osteoarthritis related gene expression assay
The sample was collected from the patient who suffered from osteoarthritis of finger joints, espcially DIP joint. The operation was perfomed due to arthrodesis procedure. So we set the outcome measurement goal for the arthrodesis successful rate.
4 years
Study Arms (1)
Hand osteoarthritis
Eligibility Criteria
1. Participating patients must be at least 45 years of age. 2. All Patients must have radiographic hand OA. 3. All Patients must be of Han Chinese ethnic background. 4. Enrolled participants must give voluntary written consents to participate in this study.
You may not qualify if:
- Patients with the following diseases will be excluded：Rheumatoid arthritis, Gout arthritis, Psoriatic arthropathy, Hypertrophic osteoarthropathy, Hypermotility syndrome, Hemochromatosis, Post-traumatic OA, Other secondary-form OA and Lupus.
- The individual is excluded if the hand X-rays show MCP changes compatible with hemochromatosis. The site then is obligated to measure fasting transferrin saturation (FE/TIBC ratio) and if \>55%, the individual is excluded.
- Have more than 3 swollen MCP joints equal to, or greater than KL grade 2.
- Be unable to give informed consent.
- One cannot participate in this study if other members of his or her immediate family have already been recruited (Only one person from each family can participate in the study).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan
Study Officials
- STUDY DIRECTOR
Chih-Hao Chang
Department of Orthopedics, National Taiwan University Hospital and National Taiwan University College of Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2013
First Posted
November 11, 2013
Study Start
February 1, 2012
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
November 11, 2013
Record last verified: 2013-11