Calprotectin and Ischemia Modified Albumin Serum to Measure Disease Activity in Behçet's Disease

Evaluation of Calprotectin and Ischemia Modified Albumin Serum Levels as Biomarkers to Measure Disease Activity in Behçet's Disease

Behçet's Disease activity was evaluated using BD Current Activity Form (BDCAF). Serum calprotectin and IMA concentrations were compared among active BD cases, inactive BD cases and control subjects.

Study Overview

• Status: Completed
• Conditions: Behçet's Diseasecases
• Intervention / Treatment: Diagnostic test: Serum calprotectin and IMA concentrations

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt
    • Mansoura University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Sixty BD cases diagnosed by the International Study Group classification criteria for BD were included. BD cases were recruited from the outpatient clinic of Rheumatology and Rehabilitation Department, Mansoura University Hospitals. The study also included 60 age- and gender-matched normal subjects served as controls.

Description

Inclusion Criteria:

• new case of Behçet's disease available medical record Well known duration of BD, Well known current treatment used Well known current organ involvement

Exclusion Criteria:

• concomitant autoimmune or auto-inflammatory disorder; acute or chronic infections; cancer; diabetes; heart failure; gestation or up to six months after birth

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control	Diagnostic test: Serum calprotectin and IMA concentrations; Serum calprotectin and IMA concentrations were compared among active BD cases, inactive BD cases and control subjects.
Patients	Diagnostic test: Serum calprotectin and IMA concentrations; Serum calprotectin and IMA concentrations were compared among active BD cases, inactive BD cases and control subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BD activity was evaluated using BD Current Activity Form (BDCAF).	BD activity was assessed with BDCAF which assesse clinical characteristics present during the previous one month before evaluation. BDCAF include the following components: headaches; mouth ulcers; erythema; genital ulcers; arthritis; arthralgia; nausea/emesis/pain in abdomen; rectal bleeding; diarrhea; and new ocular, vascular, and nervous symptoms. Each component takes a score of (0) if absent or (1) if present [30]. The total BDCAF score was calculated by adding up the positive components (maximum score = 12). A BDCAF patient index score ≥2 was considered as active BD, while a score less than 2 was considered as inactive BD	3 years
Serum calprotectin concentrations	Blood samples were withdrawn from all participants 12 h after fasting. Samples underwent centrifugation at 4000 rpm for ten minutes. The sera were collected and kept at -80°C till analysis. Serum calprotectin concentrations were quantified utilizing a commercial calprotectin ELISA kit (Hycult Biotech Inc, US) based on manufacturer's instructions. Levels of high-sensitivity CRP (hsCRP) and albumin were detected using the immunoturbidimetric technique. Unit of measurment (μg/ml )	3 years
Ischaemia Modified Albumin (IMA) serum concentrations	IMA was quantified based on albumin cobalt binding colorimetric assay according to Bar-Or and colleagues and the levels were expressed in absorbance units (ABSU). To obtain corrected IMA values, the equation (individual albumin level/median albumin level of population) × IMA ABSU value was applied. Unit of measurment ( kU/L)	3 years

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Sherin Mashaly, MD, Professor of Rheumatology and Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Eye Diseases; Genetic Diseases, Inborn; Stomatognathic Diseases; Mouth Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Vasculitis; Hereditary Autoinflammatory Diseases; Skin Diseases, Genetic; Skin Diseases, Vascular; Ischemia; Behcet Syndrome
• Other Study ID Numbers: R.22.10.1905 - 2022/10/17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No