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

Sponsor
Mansoura University (Other)
Overall Status
Completed
CT.gov ID
NCT05868538
Collaborator
(none)
60
1
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Serum calprotectin and IMA concentrations

Study Design

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Evaluation of Calprotectin and Ischemia Modified Albumin Serum Levels as Biomarkers to Measure Disease Activity in Behçet's Disease
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Mar 1, 2023
Actual Study Completion Date :
Mar 15, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. BD activity was evaluated using BD Current Activity Form (BDCAF). [3 years]

    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

  2. Serum calprotectin concentrations [3 years]

    Blood samples were withdrawn from all participants 12 h after fasting.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. Ischaemia Modified Albumin (IMA) serum concentrations [3 years]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura University Hospital Mansoura Egypt

Sponsors and Collaborators

  • Mansoura University

Investigators

  • Study Chair: Sherin Mashaly, MD, Professor of Rheumatology and Rehabilitation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mansoura University
ClinicalTrials.gov Identifier:
NCT05868538
Other Study ID Numbers:
  • R.22.10.1905 - 2022/10/17
First Posted:
May 22, 2023
Last Update Posted:
May 22, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 22, 2023