Hand OsteoarthritisNCT01981265
Genome-wide Study for Disease Susceptibility Gene(s) in Patients With Hand Osteoarthritis
An observational study of Hand Osteoarthritis, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Osteoarthritis
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2012to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chih-Hao Chang, 886-2-23213456 ext. 65987, mike920@gmail.com
About this study
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.
- Conditions
- Hand Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hand osteoarthritis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startFeb 2012
- Primary completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih-Hao Chang, Study director, Department of Orthopedics, National Taiwan University Hospital and National Taiwan University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981265
- Sponsor's protocol ID
- 201109024RC
- Status last verified
- Nov 2013
- First submitted
- 5 Nov 2013
- Last updated
- 11 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genome-wide Study for Disease Susceptibility Gene(s) in Patients With Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT01981265
- Acronym / sponsor ID
- 201109024RC
- Conditions
- Hand Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hand osteoarthritis | – | – |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
Related trials for Hand Osteoarthritis
Active, not recruiting
Balneotherapy in Hand Osteoarthritis
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Methotrexate in Erosive Inflammatory Hand Osteoarthritis
Hand Osteoarthritis, Erosive Osteoarthritis
Recruiting
Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy
Thumb Osteoarthritis, Thumb Carpometacarpal Joint Osteoarthritis
Active, not recruitingPhase 2
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis
Osteoarthritis Hand
RecruitingPhase 2/3
Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments
Erosive Hand Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chih-Hao Chang study director
Department of Orthopedics, National Taiwan University Hospital and National Taiwan University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Osteoarthritis, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chih-Hao Chang (886-2-23123456 ext. 65987, mike920@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand Osteoarthritis related gene expression assay (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2013.