SLENCT04234633
Effect of Gender on Clinical Presentation of SLE ِAt Assiut University Hospitals
An observational study of SLE, run by Assiut University.
Trial summary
The investigators aim to compare the clinical characteristics and outcomes of SLE between male and female Egyptian patients at Assuit University Hospital. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- SLE
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Mar 2022
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Any SLE patients between 18and 40 years old will be eligible to be included in our study.
Who may be able to join
- Any SLE patients between 18and 40 years old will be eligible to be included in our study.
Who cannot join
- Patients below the age of 18 or above 40.
- Any other autoimmune disease.
- Cardiovascular, neurological, renal complications due to other co-morbidity such as DM and HTN.
Trial locations and contacts
No sites are listed yet.
About this study
The investigators aim to compare the clinical characteristics and outcomes of SLE between male and female Egyptian patients at Assuit University Hospital.
Read the detailed description
Systemic lupus erythematosus (SLE) is an autoimmune disease of unknown etiology and is characterized by a multifaceted clinical presentation and disease course. Female predominance is a well-known characteristic of SLE, particularly during the reproductive years. Sex differences are another peculiarity of SLE with respect to clinical manifestations and outcomes. Previous studies have recognized male patients with lupus as a distinct minority; such patients often exhibit a poorer prognosis, especially involving the renal, cardiovascular, and neurologic systems. Higher mortality rates in male than in female patients with SLE have also been reported. Andrade et al reported that multiple conditions (for example, severe skin lesions, serositis, thrombotic events, and seizures) are more frequent in males than females.
Lu et al investigated the frequency of renal failure and end-stage renal disease among both genders and found out that these conditions were more prevalent among males. Another study shows no difference in complications and prognosis between both genders.
The results of these previous studies may not be applicable to all ethnic groups. For example, Mok et al studied the males in the local Chinese population had different disease features in term of clinical features at diagnosis, rate, and severity of relapse, organ damage and cumulative damage score. They found through a retrospective review that at the time of diagnosis, there was a trend, however not statistically significant, that males had less Raynaud's, alopecia, arthritis, anti-Ro antibody, but more thrombocytopenia and discoid lesions. Also, a significantly higher number of males had impaired renal functions.
There are few studies that have assessed the differences between male and female Egyptian patients with SLE according to the presentation, complication, prognosis, and mortality. One of these studies shows a more aggressive disease detected in male patients. This was evident by a higher prevalence of nephritis, fever, cutaneous vasculitis in male patients. on the other hand, alopecia and arthritis were significantly higher in females.
- Conditions
- SLE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SLE patients | Any SLE patients between 18 and 40 years old. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presentation, complication, and mortality among males and female patients with SLE
Using percentages, we will track the number of patients that develop certain clinical conditions (such as arthritis, malar rash, .... ), complications (such as nephritis), and mortality rates. These numbers and percentages will be used to compare males with females (incidence rates for each event will be calculated).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study startMar 2020 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SLEStudies of the same condition, open and under way.
- More trials run by Assiut 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 only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Safwat ِِِAbd elhamid eltaih, Assiut University
- Investigators
- Ahmed Aeltaih, MBBch, Principal investigator, Assuit University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234633
- Sponsor's protocol ID
- A44
- Status last verified
- Jan 2020
- First submitted
- 11 Jan 2020
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No data will be shared.
Publications
Mok CC, Lau CS, Chan TM, Wong RW. Clinical characteristics and outcome of southern Chinese males with systemic lupus erythematosus. Lupus. 1999;8(3):188-96. doi: 10.1191/096120399678847605.
PubMed 10342711Soto ME, Vallejo M, Guillen F, Simon JA, Arena E, Reyes PA. Gender impact in systemic lupus erythematosus. Clin Exp Rheumatol. 2004 Nov-Dec;22(6):713-21.
PubMed 15638045El Hadidi KT, Medhat BM, Abdel Baki NM, Abdel Kafy H, Abdelrahaman W, Yousri AY, Attia DH, Eissa M, El Dessouki D, Elgazzar I, Elgengehy FT, El Ghobashy N, El Hadary H, El Mardenly G, El Naggar H, El Nahas AM, El Refai RM, El Rwiny HA, Elsman RM, Galal M, Ghoniem S, Maged LA, Sally SM, Naji H, Saad S, Shaaban M, Sharaf M, Sobhy N, Soliman RM, El Hadidi TS. Characteristics of systemic lupus erythematosus in a sample of the Egyptian population: a retrospective cohort of 1109 patients from a single center. Lupus. 2018 May;27(6):1030-1038. doi: 10.1177/0961203317751856. Epub 2018 Feb 10.
PubMed 29431056
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gender on Clinical Presentation of SLE ِAt Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT04234633
- Acronym / sponsor ID
- A44
- Conditions
- SLE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 21 Jan 2020 (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.
The investigators aim to compare the clinical characteristics and outcomes of SLE between male and female Egyptian patients at Assuit University Hospital.
Detailed description
Systemic lupus erythematosus (SLE) is an autoimmune disease of unknown etiology and is characterized by a multifaceted clinical presentation and disease course. Female predominance is a well-known characteristic of SLE, particularly during the reproductive years. Sex differences are another peculiarity of SLE with respect to clinical manifestations and outcomes. Previous studies have recognized male patients with lupus as a distinct minority; such patients often exhibit a poorer prognosis, especially involving the renal, cardiovascular, and neurologic systems. Higher mortality rates in male than in female patients with SLE have also been reported. Andrade et al reported that multiple conditions (for example, severe skin lesions, serositis, thrombotic events, and seizures) are more frequent in males than females.
Lu et al investigated the frequency of renal failure and end-stage renal disease among both genders and found out that these conditions were more prevalent among males. Another study shows no difference in complications and prognosis between both genders.
The results of these previous studies may not be applicable to all ethnic groups. For example, Mok et al studied the males in the local Chinese population had different disease features in term of clinical features at diagnosis, rate, and severity of relapse, organ damage and cumulative damage score. They found through a retrospective review that at the time of diagnosis, there was a trend, however not statistically significant, that males had less Raynaud's, alopecia, arthritis, anti-Ro antibody, but more thrombocytopenia and discoid lesions. Also, a significantly higher number of males had impaired renal functions.
There are few studies that have assessed the differences between male and female Egyptian patients with SLE according to the presentation, complication, prognosis, and mortality. One of these studies shows a more aggressive disease detected in male patients. This was evident by a higher prevalence of nephritis, fever, cutaneous vasculitis in male patients. on the other hand, alopecia and arthritis were significantly higher in females.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLE patients | – | –Any SLE patients between 18 and 40 years old. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Any SLE patients between 18and 40 years old will be eligible to be included in our study.
Key inclusion criteria (1 listed)
- Any SLE patients between 18and 40 years old will be eligible to be included in our study.
Key exclusion criteria (3 listed)
- Patients below the age of 18 or above 40.
- Any other autoimmune disease.
- Cardiovascular, neurological, renal complications due to other co-morbidity such as DM and HTN.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presentation, complication, and mortality among males and female patients with SLE
Time frame: 2 years
Using percentages, we will track the number of patients that develop certain clinical conditions (such as arthritis, malar rash, .... ), complications (such as nephritis), and mortality rates. These numbers and percentages will be used to compare males with females (incidence rates for each event will be calculated).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Results publication: PubMed 10342711Mok CC, Lau CS, Chan TM, Wong RW. Clinical characteristics and outcome of southern Chinese males with systemic lupus erythematosus. Lupus. 1999;8(3):188-96. doi: 10.1191/096120399678847605.
- Results publication: PubMed 15638045Soto ME, Vallejo M, Guillen F, Simon JA, Arena E, Reyes PA. Gender impact in systemic lupus erythematosus. Clin Exp Rheumatol. 2004 Nov-Dec;22(6):713-21.
- Results publication: PubMed 29431056El Hadidi KT, Medhat BM, Abdel Baki NM, Abdel Kafy H, Abdelrahaman W, Yousri AY, Attia DH, Eissa M, El Dessouki D, Elgazzar I, Elgengehy FT, El Ghobashy N, El Hadary H, El Mardenly G, El Naggar H, El Nahas AM, El Refai RM, El Rwiny HA, Elsman RM, Galal M, Ghoniem S, Maged LA, Sally SM, Naji H, Saad S, Shaaban M, Sharaf M, Sobhy N, Soliman RM, El Hadidi TS. Characteristics of systemic lupus erythematosus in a sample of the Egyptian population: a retrospective cohort of 1109 patients from a single center. Lupus. 2018 May;27(6):1030-1038. doi: 10.1177/0961203317751856. Epub 2018 Feb 10.
- Individual participant dataSharing planned: Undecided. No data will be shared.
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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.
Ahmed Aeltaih, MBBch principal investigator
Assuit University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of SLE, run by Assiut 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 3 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 21 Jan 2020. 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 Aeltaih, MBBch (+201159486891, a.safwat.4842@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presentation, complication, and mortality among males and female patients with SLE (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04234633, which also lists 3 linked publications.
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 21 Jan 2020.