Behçet's DiseaseNCT01720628
The Relationship Between Serum Levels of Angiogenin, bFGF, VEGF and Ocular Involvement in Patients With Behçet's Disease
An observational study of Behçet's Disease, run by Turkish Ophthalmology Society at 1 site in Turkey (Türkiye).
Trial summary
Objectives: Behçet's disease (BD) is a systemic vasculitis. Since vascular endothelial dysfunction plays a prominent role in the pathogenesis of the disease, we considered angiogenic cytokines as an interesting target for investigation in BD. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Behçet's Disease
- What is being tested?
- serum levels of angiogenin, bFGF, VEGF
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2011to Feb 2012
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Turkish patients fulfilling the international diagnostic criteria for Behçet's disease
Who may be able to join
- age between 18-65
- fulfilling the international diagnostic criteria for Behçet's disease
Who cannot join
- to have another systemic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University, Faculty of Medicine, Department of Ophthalmology
Ankara, 06620
About this study
Objectives: Behçet's disease (BD) is a systemic vasculitis. Since vascular endothelial dysfunction plays a prominent role in the pathogenesis of the disease, we considered angiogenic cytokines as an interesting target for investigation in BD. The aim of this study was to investigate the possible role of angiogenin, vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) in the pathogenesis of BD.
Design and Methods: Sixty five patients with BD and 21 healthy control subjects were included in the study. Serum angiogenin, bFGF and VEGF concentrations were determined by using in vitro enzyme immunoassay (ELISA) kits according to the manufacturer's instructions.
- Conditions
- Behçet's Disease
- Being tested
- serum levels of angiogenin, bFGF, VEGF
- Keywords
- Angiogenin, Behçet's disease, bFGF, VEGF
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum levels of angiogenin, bFGF, VEGFOther
Behçet's patients
| Study group | Role | What they receive |
|---|---|---|
| Behçet's patients | Serum levels of angiogenin, bFGF, VEGF levels in Behçet's patients with ocular involvement group, without ocular involvement group and control group Receives: Other: serum levels of angiogenin, bFGF, VEGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of angiogenin in Behçet's patients with or without ocular involvement
The median serum angiogenin level was significantly higher in all patients with BD than controls (P=0.001). However there was no statistically significant difference between all patients and patients with or without ocular involvement. The mean serum bFGF and the median serum VEGF levels were higher in patients with ocular involvement than all patients, patients without ocular involvement and controls. But these differences did not reach statistical significance.
Measured: 1 year
Secondary outcomes (1)
Serum levels of bFGF in Behçet's patients with or without ocular involvement
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2011
- Study completionFeb 2012
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.
- 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkish Ophthalmology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeşim Gedik Oğuz, Turkish Ophthalmology Society
- Investigators
- ali yalçındağ, Study director, * Dışkapı Yıldırım Beyazıt Training and Research Hospital, Department of Clinical Biochemistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720628
- Sponsor's protocol ID
- AFV-5813
- Status last verified
- Oct 2012
- First submitted
- 23 Oct 2012
- Last updated
- 2 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Serum Levels of Angiogenin, bFGF, VEGF and Ocular Involvement in Patients With Behçet's Disease
- ClinicalTrials.gov ID
- NCT01720628
- Acronym / sponsor ID
- AFV-5813
- Conditions
- Behçet's Disease
- Keywords
- Angiogenin, Behçet's disease, bFGF, VEGF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Turkish Ophthalmology SocietyUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 2 Nov 2012 (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.
Objectives: Behçet's disease (BD) is a systemic vasculitis. Since vascular endothelial dysfunction plays a prominent role in the pathogenesis of the disease, we considered angiogenic cytokines as an interesting target for investigation in BD. The aim of this study was to investigate the possible role of angiogenin, vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) in the pathogenesis of BD.
Design and Methods: Sixty five patients with BD and 21 healthy control subjects were included in the study. Serum angiogenin, bFGF and VEGF concentrations were determined by using in vitro enzyme immunoassay (ELISA) kits according to the manufacturer's instructions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behçet's patients | – | Other: serum levels of angiogenin, bFGF, VEGFSerum levels of angiogenin, bFGF, VEGF levels in Behçet's patients with ocular involvement group, without ocular involvement group and control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Turkish patients fulfilling the international diagnostic criteria for Behçet's disease
Key inclusion criteria (2 listed)
- age between 18-65
- fulfilling the international diagnostic criteria for Behçet's disease
Key exclusion criteria (1 listed)
- to have another systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum levels of angiogenin, bFGF, VEGFBehçet's patients | Other | Behçet's patients |
Primary outcome
Serum levels of angiogenin in Behçet's patients with or without ocular involvement
Time frame: 1 year
The median serum angiogenin level was significantly higher in all patients with BD than controls (P=0.001). However there was no statistically significant difference between all patients and patients with or without ocular involvement. The mean serum bFGF and the median serum VEGF levels were higher in patients with ocular involvement than all patients, patients without ocular involvement and controls. But these differences did not reach statistical significance.
1 secondary outcome
Serum levels of bFGF in Behçet's patients with or without ocular involvement
Time frame: 1 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 2 Nov 2012.
Related trials for Behçet's Disease
RecruitingPhase 3
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Behçet's Disease, Juvenile Psoriatic Arthritis
Not yet recruitingObservational study
Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
Not yet recruitingPhase 2
Corticotropin for Behçet's Disease: A Multicenter Randomized Controlled TrialAcronym.
Behçet's Syndrome, Behçet's Syndrome (BS)
RecruitingPhase 2
Baricitinib in the Treatment of Intestinal Behçet's Syndrome
Behcet Syndrome, Intestinal Type
RecruitingPhase 3
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
Behçet Disease
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.
ali yalçındağ study director
* Dışkapı Yıldırım Beyazıt Training and Research Hospital, Department of Clinical Biochemistry
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 Behçet's Disease, run by Turkish Ophthalmology Society at 1 site 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 2 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 2 Nov 2012. 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 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?
Serum levels of angiogenin in Behçet's patients with or without ocular involvement (time frame: 1 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 2 Nov 2012.