NCT06729112

Brief Summary

Behçet's disease (BD) is a systemic vasculitis affecting both small and large blood vessels in the venous and arterial systems. It is a multiorgan disease with various manifestations, including mucocutaneous, articular, ocular, gastrointestinal, vascular, and neurological involvements. The aim of present study is to assess pan immune inflammation value (PIN) value in BD in comparison to healthy control ,assess the PIN value in association with demographics and clinical characteristics of Behcet patients and to assess the PIN value in association with disease activity.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 8, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

December 8, 2024

Last Update Submit

December 13, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of pan immune inflammation value (PIN value) in BD in comparison to healthy control

    Using the ratio of neutrophil, monocyte, and platelet counts to lymphocyte count, NLR, MLR, and PLR were calculated. The pan immune inflammation value (PIV) was calculated by multiplying the neutrophil count (109/L) by the platelet count (109/L) and the monocyte count (109/L), and then dividing the result by the lymphocyte count (109/L).

    3 months

Study Arms (2)

Behçet's disease

Adult Behçet's disease patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease. and Accept to participate in the current study.

Diagnostic Test: pan immune inflammation value

control group

healthy matched controls

Diagnostic Test: pan immune inflammation value

Interventions

Using the ratio of neutrophil, monocyte, and platelet counts to lymphocyte count, NLR, MLR, and PLR were calculated. The pan immune inflammation value (PIV) was calculated by multiplying the neutrophil count by the platelet count and the monocyte count, and then dividing the result by the lymphocyte count.

Behçet's diseasecontrol group

Eligibility Criteria

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

Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease attending Rheumatology, Rehabilitation and Physical Medicine Department, Assiut University Hospitals.

You may qualify if:

  • Adult BD patients who fulfilling the criteria for the diagnosis by International Team for the Revision of the International Criteria for Bechet's Disease .
  • Accept to participate in the current study.

You may not qualify if:

  • Individuals with other autoimmune diseases.
  • Patients unwilling to participate in the study.
  • Patients less than 18 years old.
  • Patients with malignancy or infections.
  • Pregnancy and lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospitals

Asyut, 71111, Egypt

RECRUITING

Related Publications (3)

  • Yazici Y, Hatemi G, Bodaghi B, Cheon JH, Suzuki N, Ambrose N, Yazici H. Behcet syndrome. Nat Rev Dis Primers. 2021 Sep 16;7(1):67. doi: 10.1038/s41572-021-00301-1.

    PMID: 34531393BACKGROUND
  • Bettiol A, Prisco D, Emmi G. Behcet: the syndrome. Rheumatology (Oxford). 2020 May 1;59(Suppl 3):iii101-iii107. doi: 10.1093/rheumatology/kez626.

    PMID: 32348523BACKGROUND
  • Fuca G, Guarini V, Antoniotti C, Morano F, Moretto R, Corallo S, Marmorino F, Lonardi S, Rimassa L, Sartore-Bianchi A, Borelli B, Tampellini M, Bustreo S, Claravezza M, Boccaccino A, Murialdo R, Zaniboni A, Tomasello G, Loupakis F, Adamo V, Tonini G, Cortesi E, de Braud F, Cremolini C, Pietrantonio F. The Pan-Immune-Inflammation Value is a new prognostic biomarker in metastatic colorectal cancer: results from a pooled-analysis of the Valentino and TRIBE first-line trials. Br J Cancer. 2020 Aug;123(3):403-409. doi: 10.1038/s41416-020-0894-7. Epub 2020 May 19.

    PMID: 32424148BACKGROUND

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

Study Officials

  • Sara Farrag, Lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Farrag, Lecturer

CONTACT

Eman Mohamed, Lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Rheumatology and Rehabilitation

Study Record Dates

First Submitted

December 8, 2024

First Posted

December 11, 2024

Study Start

December 1, 2023

Primary Completion

January 1, 2025

Study Completion

March 1, 2025

Last Updated

December 17, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations