Behçet's DiseaseNCT01780363
MEVALONATE KINASE GENE MUTATIONS AND THEIR CLINICAL CORRELATIONS IN BEHÇET'S DISEASE
An observational study of Behçet's Disease, run by Cukurova University at 2 sites in Turkey (Türkiye).
Trial summary
Background: Genetics is suggested to play a critical role in the development of Behçet's disease (BD). Shared phenotypic features requires an approach to the differential diagnosis from periodic febrile syndromes particularly from mevalonate kinase deficiency related diseases. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behçet's Disease
- How many people
- Not given
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Jan 2011to Dec 2011
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Turkish kindred
Who may be able to join
- Behçet patients
Who cannot join
- Diagnosis of periodic fever syndromes
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Cukurova University
Adana, 01330
Didem Arslan Tas
Adana, 01330
About this study
Background: Genetics is suggested to play a critical role in the development of Behçet's disease (BD). Shared phenotypic features requires an approach to the differential diagnosis from periodic febrile syndromes particularly from mevalonate kinase deficiency related diseases. We planned to study for evaluating the frequency of mutations and their clinical significance in mevalonate kinase gene in Turkish patients with Behçet's disease.
- Conditions
- Behçet's Disease
- Medical subject headings
- Behcet Syndrome
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 |
|---|---|---|
| controls | frequency of mevalonate kinase gene frequency | |
| Behçet patients | frequency of mevalonate kinase gene mutations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of mevalonate kinase frequency in Behçet disease
Measured: One year
Secondary outcomes (1)
Mevalonate kinase gene and clinical correlations in Behçet's disease
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startJan 2011
- Primary completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behçet's DiseaseStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe 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
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem Arslan Tas, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780363
- Sponsor's protocol ID
- BH-MVK
- Other IDs
- CUTFBAP25011138, CUTFBAP2501201138
- Status last verified
- Jan 2011
- First submitted
- 29 Jan 2013
- Last updated
- 31 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEVALONATE KINASE GENE MUTATIONS AND THEIR CLINICAL CORRELATIONS IN BEHÇET'S DISEASE
- ClinicalTrials.gov ID
- NCT01780363
- Acronym / sponsor ID
- BH-MVK
- Conditions
- Behçet's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- First posted
- 31 Jan 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.
Background: Genetics is suggested to play a critical role in the development of Behçet's disease (BD). Shared phenotypic features requires an approach to the differential diagnosis from periodic febrile syndromes particularly from mevalonate kinase deficiency related diseases. We planned to study for evaluating the frequency of mutations and their clinical significance in mevalonate kinase gene in Turkish patients with Behçet's disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| controls | – | –frequency of mevalonate kinase gene frequency |
| Behçet patients | – | –frequency of mevalonate kinase gene mutations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Turkish kindred
Key inclusion criteria (1 listed)
- Behçet patients
Key exclusion criteria (1 listed)
- Diagnosis of periodic fever syndromes
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
Frequency of mevalonate kinase frequency in Behçet disease
Time frame: One year
1 secondary outcome
Mevalonate kinase gene and clinical correlations in Behçet's disease
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behçet's Disease, run by Cukurova University at 2 sites in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of mevalonate kinase frequency in Behçet disease (time frame: One year). 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 31 Jan 2013.