Genome-wide Study for Disease Susceptibility Gene(s) in P... | NCT01981265

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

NCT01981265

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Nov 11, 2013Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Hand Osteoarthritis

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Nov 2016Estimated

Completion Date

Nov 2016Estimated

First Submitted Date

Nov 5, 2013

First Submission Date that Met QC Criteria

Nov 5, 2013

First Posted Date

Nov 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2013

Last Update Posted Date

Nov 11, 2013Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
Hand osteoarthritis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Participating patients must be at least 45 years of age.
All Patients must have radiographic hand OA.
All Patients must be of Han Chinese ethnic background.
Enrolled participants must give voluntary written consents to participate in this study.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chih-Hao Chang	Contact	886-2-23123456	65987	mike920@gmail.com
Ming Ta Michael Lee	Contact	886-2-27899077		mikelee@ibms.sinica.edu.tw

Overall Officials

Name	Affiliation	Role
Chih-Hao Chang	Department of Orthopedics, National Taiwan University Hospital and National Taiwan University College of Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei			Taiwan