NCT04105439

Brief Summary

The purpose of the study is to determine whether plasma levels of the soluble urokinase plasminogen activator(suPAR) can serve as a blood-based biomarker for diagnosis of Behçet's disease and its correlation with disease activity.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
1.8 years until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

September 25, 2019

Last Update Submit

January 11, 2021

Conditions

Behçet Disease

Outcome Measures

Primary Outcomes (1)

  • evaluation of the level of suPAR in the study subjects.

    to study the relation between leve of the marker and presence of the diesase.

    baseline

Secondary Outcomes (1)

  • evaluation of the levels of suPAR with the activity of the disease.

    baseline

Study Arms (2)

control

healthy subjects who do not have the disease

patients with Behçet's disease

subjects who do have the disease ( Behçet's disease )

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients age ≥ 18 years old and are diagnosed as Behçet's disease according to international study group criteria (ICBD ) for diagnosiss of Behçet's

You may qualify if:

  • Age ≥ 18
  • Patients diagnosed as Behçet's disease according to international study group criteria (ICBD ) for diagnosis of Behçet's

You may not qualify if:

  • Age\< 18 years
  • Other autoimmune diseases.
  • Pregnancy.
  • Acute and chronic systemic infection history.
  • The presence of chronic diseases such as chronic renal failure, liver and cardiac failure.
  • Presence or history of cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Criteria for diagnosis of Behcet's disease. International Study Group for Behcet's Disease. Lancet. 1990 May 5;335(8697):1078-80.

    PMID: 1970380BACKGROUND

  • Koc Y, Gullu I, Akpek G, Akpolat T, Kansu E, Kiraz S, Batman F, Kansu T, Balkanci F, Akkaya S, et al. Vascular involvement in Behcet's disease. J Rheumatol. 1992 Mar;19(3):402-10.

    PMID: 1578454BACKGROUND

  • Kose O. Development of Immunopathogenesis Strategies to Treat Behcet's Disease. Patholog Res Int. 2012;2012:261989. doi: 10.1155/2012/261989. Epub 2012 Apr 3.

    PMID: 22550612BACKGROUND

  • Tursen U. Pathophysiology of the Behcet's Disease. Patholog Res Int. 2012;2012:493015. doi: 10.1155/2012/493015. Epub 2011 Oct 1.

    PMID: 21977335BACKGROUND

  • International Team for the Revision of the International Criteria for Behcet's Disease (ITR-ICBD). The International Criteria for Behcet's Disease (ICBD): a collaborative study of 27 countries on the sensitivity and specificity of the new criteria. J Eur Acad Dermatol Venereol. 2014 Mar;28(3):338-47. doi: 10.1111/jdv.12107. Epub 2013 Feb 26.

    PMID: 23441863BACKGROUND

  • Adam B, Calikoglu E. Serum interleukin-6, procalcitonin and C-reactive protein levels in subjects with active Behcet's disease. J Eur Acad Dermatol Venereol. 2004 May;18(3):318-20. doi: 10.1111/j.1468-3083.2004.00907.x.

    PMID: 15096143BACKGROUND

  • Gustafsson A, Ljunggren L, Bodelsson M, Berkestedt I. The Prognostic Value of suPAR Compared to Other Inflammatory Markers in Patients with Severe Sepsis. Biomark Insights. 2012;7:39-44. doi: 10.4137/BMI.S9460. Epub 2012 Apr 10.

    PMID: 22550400BACKGROUND

  • Thuno M, Macho B, Eugen-Olsen J. suPAR: the molecular crystal ball. Dis Markers. 2009;27(3):157-72. doi: 10.3233/DMA-2009-0657.

    PMID: 19893210BACKGROUND

Related Links

MeSH Terms

Conditions

Behcet Syndrome

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

Central Study Contacts

Mohamed Farghaly Ramadan, MD

CONTACT

01120782662el.5abiry@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 26, 2019

Study Start

July 1, 2021

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

January 13, 2021

Record last verified: 2021-01