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

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ClinicalTrials.gov Identifier: NCT01981265
Recruitment Status : Unknown
Verified November 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : November 11, 2013
Last Update Posted : November 11, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.


Condition or disease
Hand Osteoarthritis

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Genome-wide Study for Disease Susceptibility Gene(s) in Patients With Hand Osteoarthritis
Study Start Date : February 2012
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Hand osteoarthritis



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981265


Contacts
Contact: Chih-Hao Chang 886-2-23123456 ext 65987 mike920@gmail.com
Contact: Ming Ta Michael Lee 886-2-27899077 mikelee@ibms.sinica.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Chih-Hao Chang    886-2-23213456 ext 65987    mike920@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Chih-Hao Chang Department of Orthopedics, National Taiwan University Hospital and National Taiwan University College of Medicine

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01981265     History of Changes
Other Study ID Numbers: 201109024RC
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Osteoarthritis
Disease Susceptibility
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Disease Attributes
Pathologic Processes