Behçet's DiseasecasesNCT05868538
Calprotectin and Ischemia Modified Albumin Serum to Measure Disease Activity in Behçet's Disease
An observational study of Behçet's Diseasecases, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Behçet's Diseasecases
- What is being tested?
- Serum calprotectin and IMA concentrations
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 15 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- new case of Behçet's disease available medical record Well known duration of BD, Well known current treatment used Well known current organ involvement
Who cannot join
- concomitant autoimmune or auto-inflammatory disorder; acute or chronic infections; cancer; diabetes; heart failure; gestation or up to six months after birth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Behçet's Diseasecases
- Being tested
- Serum calprotectin and IMA concentrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum calprotectin and IMA concentrationsDiagnostic test
Serum calprotectin and IMA concentrations were compared among active BD cases, inactive BD cases and control subjects.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Diagnostic Test: Serum calprotectin and IMA concentrations | |
| control | Not described Receives: Diagnostic Test: Serum calprotectin and IMA concentrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 )
Measured: 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)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Apr 2019
- Primary completion1 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behçet's DiseasecasesStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sherin Mashaly, MD, Study chair, Professor of Rheumatology and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868538
- Sponsor's protocol ID
- R.22.10.1905 - 2022/10/17
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Calprotectin and Ischemia Modified Albumin Serum Levels as Biomarkers to Measure Disease Activity in Behçet's Disease
- ClinicalTrials.gov ID
- NCT05868538
- Acronym / sponsor ID
- R.22.10.1905 - 2022/10/17
- Conditions
- Behçet's Diseasecases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: Serum calprotectin and IMA concentrations |
| control | – | Diagnostic Test: Serum calprotectin and IMA concentrations |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- new case of Behçet's disease available medical record Well known duration of BD, Well known current treatment used Well known current organ involvement
Key exclusion criteria (1 listed)
- concomitant autoimmune or auto-inflammatory disorder; acute or chronic infections; cancer; diabetes; heart failure; gestation or up to six months after birth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum calprotectin and IMA concentrationsSerum calprotectin and IMA concentrations were compared among active BD cases, inactive BD cases and control subjects. | Diagnostic test | Patients, control |
Primary outcome
BD activity was evaluated using BD Current Activity Form (BDCAF).
Time frame: 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
Serum calprotectin concentrations
Time frame: 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 )
Ischaemia Modified Albumin (IMA) serum concentrations
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherin Mashaly, MD study chair
Professor of Rheumatology and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behçet's Diseasecases, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BD activity was evaluated using BD Current Activity Form (BDCAF). (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.