Behçet DiseaseNCT06451575
Thrombophilia and Thrombosis in Behçet's Disease
An observational study of Behçet Disease, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Behçet's disease (BD) is a systemic vasculitis of unknown cause, affecting mainly young adults. Vasculopathy has been reported in 16.8-51.5% of cases. Genetic, infectious factors, environmental factors, presence of autoantibodies, endothelial pathologies and hypercoagulability are responsible for the etiopathogenesis… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Behçet Disease
- What is being tested?
- Blood collection
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Sep 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 patients with Behçet's disease aged 18-70 years and 100 age- and sex-matched healthy controls
Who may be able to join
- 18-70 years old
- Patients who fulfil the international diagnostic criteria for Behçet's disease
- Those who accepted the consent form
Who cannot join
- Those under 18 years of age
- accompanied by another inflammatory dermatological disease
- Pregnancy and breastfeeding
- Those who use drugs that increase the tendency to thrombosis -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erdal Pala
Erzurum, Üniversite Mahallesi, 25240
ERDAL PALA, +95383753661, erdalpala2525@gmail.com
Zeynep karaca Ural
About this study
Official title: Thrombophilia and Tendency to Thrombosis in Behçet's Disease
Behçet's disease (BD) is a systemic vasculitis of unknown cause, affecting mainly young adults. Vasculopathy has been reported in 16.8-51.5% of cases. Genetic, infectious factors, environmental factors, presence of autoantibodies, endothelial pathologies and hypercoagulability are responsible for the etiopathogenesis of BD. The main involvements responsible for morbidity and mortality in Behçet's disease are ocular, major cardiovascular and neurological involvements. Although there is an increased thrombotic risk in the etiopathogenesis of Behçet's disease, the cellular and molecular mechanisms are not fully understood. Although endothelial dysfunction due to inflammation has been shown to be the primary cause of vascular damage in Behçet's disease, some clinical evidence suggests that hypercoagulable states also contribute to thrombosis. The most common form of vascular involvement in Behçet's disease is deep vein thrombosis in the lower extremities. Arterial occlusion mostly affects the subclavian and pulmonary arteries. Although arterial involvement is rarer than venous involvement in Behçet's disease, morbidity and mortality are higher than venous involvement.
Although an increased thrombotic risk is mentioned in the etiopathogenesis of Behçet's disease, it is still controversial whether vasculitis or susceptibility to hypercoagulability plays a role in the pathogenesis of venous thrombosis. In addition, there are very few studies in the literature in which all thrombophilic parameters were analysed. Again, there is no recent study on this subject. The aim of our study is to determine the risk of hypercoagulability in Behçet's disease patients with vascular involvement, which has a highly mortal course.
Read the detailed description
The study was planned as a prospective case control study. The study will be conducted on 100 Behçet's patients aged 18-70 years who were diagnosed with Behçet's disease according to the International Behçet's diagnostic criteria and 100 healthy controls similar in age and gender who applied to Atatürk University Faculty of Medicine Dermatology outpatient clinic between June 2023 and September 2024. Routine clinical evaluations of all patients will be performed. Demographic characteristics (age, gender), clinical features of the disease and medications used will be recorded. Patients will be included in the study after the relevant department consultations for system involvement. Skin and mucous membrane findings seen in the last 1 month will be recorded. Blood samples will be taken from all participants and analysed in the Genetics laboratory of our hospital. DNA isolation will be performed with DNA isolation kit from peripheral blood in EDTA tube taken from patients during routine examinations. DNA samples will be stored at -20 degrees Celsius until the time of the study. After collecting the targeted number of samples, Factor II G20210A, Factor V Leiden G1691A, MTHFR (Methylene Tetra Hydro Folate Reductase) C677T, MTHFR A1298C, Factor XIII V34L, PAI (Plasminogen Activator Inhibitor-1) 4G/5G SNP (single nucleotide polymorphisms) analyses will be performed with the thrombophilia panel kit. This analysis will be performed by fragment analysis method on the ABI 3130 Genetic analyser device in the Medical Genetics Laboratory. Firstly, PCR study will be performed with the thrombophilia panel kit, the plate with patient DNA will be loaded into the capillary electrophoresis device and the analyses will be interpreted and finalised with GeneMapper software.
- Conditions
- Behçet Disease
- Being tested
- Blood collection
- Keywords
- thrombosis, thrombophilia, Behcet's disease
- Medical subject headings
- Behcet Syndrome, Thrombosis, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionDiagnostic test
Blood collection
| Study group | Role | What they receive |
|---|---|---|
| Cases with Behcet's disease | Behcet's disease Receives: Diagnostic Test: Blood collection | |
| healthy individuals | Healthy control group Receives: Diagnostic Test: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Faktor II G20210A kit
Faktor II G20210A at 200 participants
Measured: 15 months
Faktor V Leiden kit
Faktor V Leiden at 200 participants
Measured: 15 months
G1691A kit
G1691A at 200 participants
Measured: 15 months
MTHFR (Methylene Tetra Hydro Folate Reductase) kit
MTHFR (Methylene Tetra Hydro Folate Reductase) at 200 participants
Measured: 15 months
C677T kit
C677T at 200 participants
Measured: 15 months
Factor XIII kit
Factor XIII at 200 participants
Measured: 15 months
With DNA isolation kit
PAI (Plasminogen Activator Inhibitor-1) at 200 participants
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Jun 2023
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behçet DiseaseStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erdal Pala, Ataturk University
- Investigators
- ERDAL PALA, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451575
- Sponsor's protocol ID
- 30.03.2023/219
- Status last verified
- Jun 2024
- First submitted
- 23 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombophilia and Tendency to Thrombosis in Behçet's Disease
- ClinicalTrials.gov ID
- NCT06451575
- Acronym / sponsor ID
- 30.03.2023/219
- Conditions
- Behçet Disease
- Keywords
- thrombosis, thrombophilia, Behcet's disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 11 Jun 2024 (actual)
- 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.
Behçet's disease (BD) is a systemic vasculitis of unknown cause, affecting mainly young adults. Vasculopathy has been reported in 16.8-51.5% of cases. Genetic, infectious factors, environmental factors, presence of autoantibodies, endothelial pathologies and hypercoagulability are responsible for the etiopathogenesis of BD. The main involvements responsible for morbidity and mortality in Behçet's disease are ocular, major cardiovascular and neurological involvements. Although there is an increased thrombotic risk in the etiopathogenesis of Behçet's disease, the cellular and molecular mechanisms are not fully understood. Although endothelial dysfunction due to inflammation has been shown to be the primary cause of vascular damage in Behçet's disease, some clinical evidence suggests that hypercoagulable states also contribute to thrombosis. The most common form of vascular involvement in Behçet's disease is deep vein thrombosis in the lower extremities. Arterial occlusion mostly affects the subclavian and pulmonary arteries. Although arterial involvement is rarer than venous involvement in Behçet's disease, morbidity and mortality are higher than venous involvement.
Although an increased thrombotic risk is mentioned in the etiopathogenesis of Behçet's disease, it is still controversial whether vasculitis or susceptibility to hypercoagulability plays a role in the pathogenesis of venous thrombosis. In addition, there are very few studies in the literature in which all thrombophilic parameters were analysed. Again, there is no recent study on this subject. The aim of our study is to determine the risk of hypercoagulability in Behçet's disease patients with vascular involvement, which has a highly mortal course.
Detailed description
The study was planned as a prospective case control study. The study will be conducted on 100 Behçet's patients aged 18-70 years who were diagnosed with Behçet's disease according to the International Behçet's diagnostic criteria and 100 healthy controls similar in age and gender who applied to Atatürk University Faculty of Medicine Dermatology outpatient clinic between June 2023 and September 2024. Routine clinical evaluations of all patients will be performed. Demographic characteristics (age, gender), clinical features of the disease and medications used will be recorded. Patients will be included in the study after the relevant department consultations for system involvement. Skin and mucous membrane findings seen in the last 1 month will be recorded. Blood samples will be taken from all participants and analysed in the Genetics laboratory of our hospital. DNA isolation will be performed with DNA isolation kit from peripheral blood in EDTA tube taken from patients during routine examinations. DNA samples will be stored at -20 degrees Celsius until the time of the study. After collecting the targeted number of samples, Factor II G20210A, Factor V Leiden G1691A, MTHFR (Methylene Tetra Hydro Folate Reductase) C677T, MTHFR A1298C, Factor XIII V34L, PAI (Plasminogen Activator Inhibitor-1) 4G/5G SNP (single nucleotide polymorphisms) analyses will be performed with the thrombophilia panel kit. This analysis will be performed by fragment analysis method on the ABI 3130 Genetic analyser device in the Medical Genetics Laboratory. Firstly, PCR study will be performed with the thrombophilia panel kit, the plate with patient DNA will be loaded into the capillary electrophoresis device and the analyses will be interpreted and finalised with GeneMapper software.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases with Behcet's disease | – | Diagnostic Test: Blood collectionBehcet's disease |
| healthy individuals | – | Diagnostic Test: Blood collectionHealthy control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 patients with Behçet's disease aged 18-70 years and 100 age- and sex-matched healthy controls
Key inclusion criteria (3 listed)
- 18-70 years old
- Patients who fulfil the international diagnostic criteria for Behçet's disease
- Those who accepted the consent form
Key exclusion criteria (4 listed)
- Those under 18 years of age
- accompanied by another inflammatory dermatological disease
- Pregnancy and breastfeeding
- Those who use drugs that increase the tendency to thrombosis -
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 |
|---|---|---|
| Blood collectionBlood collection | Diagnostic test | Cases with Behcet's disease, healthy individuals |
Primary outcome
Faktor II G20210A kit
Time frame: 15 months
Faktor II G20210A at 200 participants
Faktor V Leiden kit
Time frame: 15 months
Faktor V Leiden at 200 participants
G1691A kit
Time frame: 15 months
G1691A at 200 participants
MTHFR (Methylene Tetra Hydro Folate Reductase) kit
Time frame: 15 months
MTHFR (Methylene Tetra Hydro Folate Reductase) at 200 participants
C677T kit
Time frame: 15 months
C677T at 200 participants
Factor XIII kit
Time frame: 15 months
Factor XIII at 200 participants
With DNA isolation kit
Time frame: 15 months
PAI (Plasminogen Activator Inhibitor-1) at 200 participants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No
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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.
ERDAL PALA principal investigator
Ataturk University
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 Disease, run by Ataturk University 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 3 inclusion and 4 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 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ERDAL PALA (+95383753661, erdal.pala@atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faktor II G20210A kit (time frame: 15 months). The study lists 7 primary outcomes in all. 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 Jun 2024.