Chronic Spontaneous UrticariaNCT05992987
Assessment of Serum Levels of Adenosine Deaminase and Immunoglobulin E in Patients With Chronic Spontaneous Urticaria
An observational study of Chronic Spontaneous Urticaria, run by Sohag University.
Trial summary
adenosine deaminase activity (ADA) has been reported to be elevated in various diseases such as psoriasis, acne and juvenile idiopathic arthritis. There is no previous studies that assessed ADA in chronic spontaneous urticaria (CSU) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- Adenosine deaminase serum level and IgE antibodies serum level
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2023to 31 Mar 2024
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Settings: Dermatology outpatient clinics and Central Research Lab at Sohag University. Study population: The study will include adult patients complaining of CSU and a group of age and sex-matched healthy controls (blood donors).
Who may be able to join
- adult patients complaining of CSU and a group of age and sex-matched healthy controls (blood donors).
Who cannot join
- Pregnancy and lactation.
- Patients with systemic diseases, especially those with autoimmune diseases and infections.
- Patients with skin diseases.
- Patients on medications such as antibiotics, nonsteroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, anticonvulsants, penicillin, and combined oral contraceptives.
Trial locations and contacts
No sites are listed yet.
About this study
adenosine deaminase activity (ADA) has been reported to be elevated in various diseases such as psoriasis, acne and juvenile idiopathic arthritis. There is no previous studies that assessed ADA in chronic spontaneous urticaria (CSU) .
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- Adenosine deaminase serum level, IgE antibodies serum level
- Keywords
- chronic spontaneous urticaria, adenosine deaminase, immunoglobulin E
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenosine deaminase serum levelDiagnostic test
Adenosine deaminase will be measured by enzymatic (clorometric / kinetic) method (Diazyme laboratories, San Diego, California, USA).
IgE antibodies serum levelDiagnostic test
Level of IgE will be measured by electrochemiluminesence immunoassay (ECLIA, automatic cobase immunoassay, Roche Diagnostics GmbH, Mannheim, USA).
| Study group | Role | What they receive |
|---|---|---|
| CSU group | Adult patients complaining of chronic spontaneous urticaria (CSU) Receives: Diagnostic Test: Adenosine deaminase serum level; Diagnostic Test: IgE antibodies serum level | |
| Control group | A group of age and sex-matched healthy controls (blood donors). Receives: Diagnostic Test: Adenosine deaminase serum level; Diagnostic Test: IgE antibodies serum level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum level of adenosine deaminase
Difference in serum level of adenosine deaminase between CSU group and control group
Measured: 3 months
Serum level of IgE
Difference in serum level of IgE between CSU group and control group
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start15 Aug 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed, Sohag University
- Investigators
- Ramadan Saleh, MD, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992987
- Sponsor's protocol ID
- Soh-Med-23-07-12MS
- Status last verified
- Jul 2023
- First submitted
- 7 Aug 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: IPD will be shared upon request to the study director
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Serum Levels of Adenosine Deaminase and Immunoglobulin E in Patients With Chronic Spontaneous Urticaria
- ClinicalTrials.gov ID
- NCT05992987
- Acronym / sponsor ID
- Soh-Med-23-07-12MS
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- chronic spontaneous urticaria, adenosine deaminase, immunoglobulin E
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 15 Aug 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.
adenosine deaminase activity (ADA) has been reported to be elevated in various diseases such as psoriasis, acne and juvenile idiopathic arthritis. There is no previous studies that assessed ADA in chronic spontaneous urticaria (CSU) .
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSU group | – | Diagnostic Test: Adenosine deaminase serum level, Diagnostic Test: IgE antibodies serum levelAdult patients complaining of chronic spontaneous urticaria (CSU) |
| Control group | – | Diagnostic Test: Adenosine deaminase serum level, Diagnostic Test: IgE antibodies serum levelA group of age and sex-matched healthy controls (blood donors). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Settings: Dermatology outpatient clinics and Central Research Lab at Sohag University. Study population: The study will include adult patients complaining of CSU and a group of age and sex-matched healthy controls (blood donors).
Key inclusion criteria (1 listed)
- adult patients complaining of CSU and a group of age and sex-matched healthy controls (blood donors).
Key exclusion criteria (4 listed)
- Pregnancy and lactation.
- Patients with systemic diseases, especially those with autoimmune diseases and infections.
- Patients with skin diseases.
- Patients on medications such as antibiotics, nonsteroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, anticonvulsants, penicillin, and combined oral contraceptives.
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 |
|---|---|---|
| Adenosine deaminase serum levelAdenosine deaminase will be measured by enzymatic (clorometric / kinetic) method (Diazyme laboratories, San Diego, California, USA). | Diagnostic test | CSU group, Control group |
| IgE antibodies serum levelLevel of IgE will be measured by electrochemiluminesence immunoassay (ECLIA, automatic cobase immunoassay, Roche Diagnostics GmbH, Mannheim, USA). | Diagnostic test | CSU group, Control group |
Primary outcome
Serum level of adenosine deaminase
Time frame: 3 months
Difference in serum level of adenosine deaminase between CSU group and control group
Serum level of IgE
Time frame: 3 months
Difference in serum level of IgE between CSU group and control group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Individual participant dataSharing planned: Yes. IPD will be shared upon request to the study director
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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.
Ramadan Saleh, MD study director
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Spontaneous Urticaria, run by Sohag University.
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 4 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: status not confirmed, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Ahmed, M.B.B.Ch (+201093593974, Dr.ahmed.elsheikh94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum level of adenosine deaminase (time frame: 3 months). The study lists 2 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 15 Aug 2023.