NCT01720628

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
Last Updated

November 2, 2012

Status Verified

October 1, 2012

Enrollment Period

Same day

First QC Date

October 23, 2012

Last Update Submit

October 31, 2012

Conditions

Keywords

Angiogenin, Behçet's disease, bFGF, VEGF

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (1)

  • Serum levels of bFGF in Behçet's patients with or without ocular involvement

    1 year

Other Outcomes (1)

  • Serum levels of VEGF in Behçet's patients with or without ocular involvement

    1 year

Study Arms (1)

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

Other: serum levels of angiogenin, bFGF, VEGF

Interventions

Behçet's patients

Behçet's patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Turkish patients fulfilling the international diagnostic criteria for Behçet's disease

You may qualify if:

  • age between 18-65
  • fulfilling the international diagnostic criteria for Behçet's disease

You may not qualify if:

  • to have another systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University, Faculty of Medicine, Department of Ophthalmology

Ankara, 06620, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Behcet Syndrome

Interventions

Vascular Endothelial Growth Factor A

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesUveitis, AnteriorPanuveitisUveitisUveal DiseasesEye DiseasesVasculitisVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Vascular Endothelial Growth FactorsAngiogenic ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • ali yalçındağ

    * Dışkapı Yıldırım Beyazıt Training and Research Hospital, Department of Clinical Biochemistry

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 23, 2012

First Posted

November 2, 2012

Study Start

November 1, 2011

Primary Completion

November 1, 2011

Study Completion

February 1, 2012

Last Updated

November 2, 2012

Record last verified: 2012-10

Locations