Systemic Lupus Erythematosus (SLE)NCT07252141
miR-101-3p and Autotaxin in SLE Patients
An observational study of Systemic Lupus Erythematosus (SLE), run by Eman Mohamed Shawky.
Trial summary
Systemic lupus erythematosus (SLE) is a complex autoimmune disease affecting multiple organs and characterized by heterogeneous clinical manifestations. This case-control study aims to assess the association between serum expression levels of MicroRNA-101-3p and Autotaxin (ATX) in SLE patients compared with healthy… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 30 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include 40 patients diagnosed with systemic lupus erythematosus (SLE) according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria and 40 age- and sex-matched healthy controls. Patients will be recruited from the Rheumatology and Rehabilitation Department and Internal Medicine Department (Rheumatology Unit) at Assiut University Hospitals, Egypt.
Who may be able to join
- Study Population: Adult patients diagnosed with systemic lupus erythematosus and healthy matched controls.
- - Age ≥ 18 years
- Diagnosis of SLE according to 2012 SLICC criteria
- Willingness to participate and provide informed consent
Who cannot join
- Pregnancy or lactation
- Active infections or malignancy
- Co-existing autoimmune diseases
- Refusal to participate
About this study
Official title: Association Between the Expression Levels of MicroRNA-101-3p and Autotaxin in Serum of Systemic Lupus Erythematosus Patients
Systemic lupus erythematosus (SLE) is a complex autoimmune disease affecting multiple organs and characterized by heterogeneous clinical manifestations. This case-control study aims to assess the association between serum expression levels of MicroRNA-101-3p and Autotaxin (ATX) in SLE patients compared with healthy controls. The hypothesis is that dysregulation of miR-101-3p and ATX contributes to SLE pathogenesis and may serve as potential non-invasive biomarkers for disease activity and prognosis.
Read the detailed description
This descriptive case-control study will enroll 40 SLE patients fulfilling the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria and 40 age- and sex-matched healthy individuals. Demographic, clinical, and laboratory data will be collected, including disease duration, activity indices (SLEDAI-2K), and damage index (SDI). Blood samples will be taken for biochemical and molecular analyses. Serum miR-101-3p expression will be quantified by qRT-PCR, while Autotaxin and IL-6 levels will be measured by ELISA. Statistical correlations between these biomarkers and clinical variables will be evaluated. The study aims to identify diagnostic and prognostic biomarkers that may guide future therapeutic targets in SLE.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Medical subject headings
- Lupus Erythematosus, Systemic
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 |
|---|---|---|
| Forty patients diagnosed with systemic lupus erythematosus and Forty healthy control group | SLE Patients Group/Cohort Description: Forty patients diagnosed with systemic lupus erythematosus according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria. Clinical and laboratory data, including disease activity indices (SLEDAI-2K and SDI), will be collected. Serum samples will be analyzed for miR-101-3p expression (qRT-PCR) and Autotaxin levels (ELISA). - Group/Cohort 2 Group/Cohort Label: Healthy Controls Group/Cohort Description: Forty age- and sex-matched healthy individuals without autoimmune, infectious, or chronic inflammatory diseases. Blood samples will be collected for serum miR-101-3p and Autotaxin assessment using the same methods applied to the patient group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of miR-101-3p and Autotaxin in SLE patients versus healthy controls
To determine the difference in serum expression levels of miR-101-3p and Autotaxin between patients with systemic lupus erythematosus (SLE) and age- and sex-matched healthy controls using qRT-PCR and ELISA.
Measured: 6 months (expected)
Secondary outcomes (1)
Correlation between miR-101-3p and Autotaxin levels
To evaluate the relationship between serum miR-101-3p and Autotaxin concentrations in SLE patients.
Measured: 6 monthes expected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start30 Dec 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eman Mohamed Shawky
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eman Mohamed Shawky, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252141
- Sponsor's protocol ID
- IRB.no: 04-2025-300546
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between the Expression Levels of MicroRNA-101-3p and Autotaxin in Serum of Systemic Lupus Erythematosus Patients
- ClinicalTrials.gov ID
- NCT07252141
- Acronym / sponsor ID
- IRB.no: 04-2025-300546
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eman Mohamed ShawkyUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 26 Nov 2025 (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.
Systemic lupus erythematosus (SLE) is a complex autoimmune disease affecting multiple organs and characterized by heterogeneous clinical manifestations. This case-control study aims to assess the association between serum expression levels of MicroRNA-101-3p and Autotaxin (ATX) in SLE patients compared with healthy controls. The hypothesis is that dysregulation of miR-101-3p and ATX contributes to SLE pathogenesis and may serve as potential non-invasive biomarkers for disease activity and prognosis.
Detailed description
This descriptive case-control study will enroll 40 SLE patients fulfilling the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria and 40 age- and sex-matched healthy individuals. Demographic, clinical, and laboratory data will be collected, including disease duration, activity indices (SLEDAI-2K), and damage index (SDI). Blood samples will be taken for biochemical and molecular analyses. Serum miR-101-3p expression will be quantified by qRT-PCR, while Autotaxin and IL-6 levels will be measured by ELISA. Statistical correlations between these biomarkers and clinical variables will be evaluated. The study aims to identify diagnostic and prognostic biomarkers that may guide future therapeutic targets in SLE.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Forty patients diagnosed with systemic lupus erythematosus and Forty healthy control group | – | –SLE Patients Group/Cohort Description: Forty patients diagnosed with systemic lupus erythematosus according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria. Clinical and laboratory data, including disease activity indices (SLEDAI-2K and SDI), will be collected. Serum samples will be analyzed for miR-101-3p expression (qRT-PCR) and Autotaxin levels (ELISA). - Group/Cohort 2 Group/Cohort Label: Healthy Controls Group/Cohort Description: Forty age- and sex-matched healthy individuals without autoimmune, infectious, or chronic inflammatory diseases. Blood samples will be collected for serum miR-101-3p and Autotaxin assessment using the same methods applied to the patient group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include 40 patients diagnosed with systemic lupus erythematosus (SLE) according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria and 40 age- and sex-matched healthy controls. Patients will be recruited from the Rheumatology and Rehabilitation Department and Internal Medicine Department (Rheumatology Unit) at Assiut University Hospitals, Egypt.
Key inclusion criteria (4 listed)
- Study Population: Adult patients diagnosed with systemic lupus erythematosus and healthy matched controls.
- - Age ≥ 18 years
- Diagnosis of SLE according to 2012 SLICC criteria
- Willingness to participate and provide informed consent
Key exclusion criteria (4 listed)
- Pregnancy or lactation
- Active infections or malignancy
- Co-existing autoimmune diseases
- Refusal to participate
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
Serum levels of miR-101-3p and Autotaxin in SLE patients versus healthy controls
Time frame: 6 months (expected)
To determine the difference in serum expression levels of miR-101-3p and Autotaxin between patients with systemic lupus erythematosus (SLE) and age- and sex-matched healthy controls using qRT-PCR and ELISA.
1 secondary outcome
Correlation between miR-101-3p and Autotaxin levels
Time frame: 6 monthes expected
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus (SLE), run by Eman Mohamed Shawky.
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 4 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: opening soon, as of the sponsor's last update on 26 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Serum levels of miR-101-3p and Autotaxin in SLE patients versus healthy controls (time frame: 6 months (expected)). 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 26 Nov 2025.