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

NCT ID: NCT01981265

Last Updated: 2013-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hand Osteoarthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Hand osteoarthritis

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chih-Hao Chang

Role: STUDY_DIRECTOR

Department of Orthopedics, National Taiwan University Hospital and National Taiwan University College of Medicine

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chih-Hao Chang

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Ming Ta Michael Lee

Role: CONTACT

Phone: 886-2-27899077

Email: [email protected]

Facility Contacts

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Chih-Hao Chang

Role: primary

Other Identifiers

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201109024RC

Identifier Type: -

Identifier Source: org_study_id