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

November 5, 2013 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

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

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  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.

Description

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 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

Cohorts and Interventions

Group / Cohort
Hand osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand Osteoarthritis related gene expression assay
Time Frame: 4 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Study Director: Chih-Hao Chang, Department of Orthopedics, National Taiwan University Hospital and National Taiwan University College of Medicine

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

February 1, 2012

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

November 5, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Estimate)

November 11, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201109024RC

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.

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