NCT03747354

Brief Summary

  • To determine platelet to lymphocyte ratio (PLR), lymphocytes to monocytes ratio (LMR), mean platelet volume (MPV) and neutrophile lymphocyte ratio (NLR), levels in Behçet's disease (BD)
  • To investigate their 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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

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

November 11, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

9 months

First QC Date

November 11, 2018

Last Update Submit

November 17, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • serum (PLR), (LMR), (MPV) and (NLR) in behcet disease and their correlation with disease activity.

    * To determine platelet to lymphocyte ratio (PLR), lymphocytes to monocytes ratio (LMR), mean platelet volume (MPV) and neutrophile lymphocyte ratio (NLR), levels in Behçet's disease (BD) * To investigate their correlation with disease activity

    baseline

Study Arms (2)

complete blood count

ACTIVE COMPARATOR

blood samples will be taken from patient and complete blood count is done early morning

Diagnostic Test: blood samples

erythrocyte sedimentation rate

ACTIVE COMPARATOR

blood samples will be taken from patient and erythrocyte sedimentation rate is done

Diagnostic Test: blood samples

Interventions

blood samplesDIAGNOSTIC_TEST

blood samples

complete blood counterythrocyte sedimentation rate

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient diagnosed as behcet disease by a rheumatologist
  • Age from 18 to 70 years old

You may not qualify if:

  • \- Skin diseases,
  • Autoimmune diseases,
  • Inflammatory or infectious diseases,
  • Allergy,
  • Subjects with chronic diseases such as cardiovascular disorders, diabetes mellitus, or hematological, kidney, or liver diseases, hypertension, or malignant diseases
  • unwilling to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jiang Y, Zang M, Li S. Serum PLR and LMR in Behcet's disease: Can they show the disease activity? Medicine (Baltimore). 2017 May;96(21):e6981. doi: 10.1097/MD.0000000000006981.

    PMID: 28538403BACKGROUND

MeSH Terms

Conditions

Behcet Syndrome

Interventions

Blood Specimen Collection

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)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • esraa omar, master

    Assiut University

    STUDY CHAIR

Central Study Contacts

esraa omar, master

CONTACT

Naema Mohamed mostafa, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

November 11, 2018

First Posted

November 20, 2018

Study Start

December 1, 2018

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share