Genome-wide Study for Disease Susceptibility Gene(s) in Patients With Hand Osteoarthritis

Hand Osteoarthritis Clinical Trial

Official title:

Genome-wide Study for Disease Susceptibility Gene(s) in Patients With Hand Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01981265
• Other study ID #: 201109024RC
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2013
• Last updated: November 5, 2013
• Start date: February 2012
• Est. completion date: November 2016

Study information

• Verified date: November 2013
• Source: National Taiwan University Hospital
• Contact: Chih-Hao Chang
• Phone: 886-2-23123456
• Email: mike920[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Exclusion Criteria:

1. 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.

2. 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.

3. Have more than 3 swollen MCP joints equal to, or greater than KL grade 2.

4. Be unable to give informed consent.

5. 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).

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease Susceptibility
• Hand Osteoarthritis
• Osteoarthritis

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes