Systemic Lupus ErythematosusNCT07136337
The Diagnostic Utility of T Immunoglobulin G and T Immunoglobulin M Biomarkers in Patients With Systemic Lupus Erythematosus Disease : Associations With Disease Activity and Damage
A study testing 4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by in people with Systemic Lupus Erythematosus, run by Assiut University at 1 site in Egypt.
Trial summary
The SLE is heterogeneous multisystem autoimmune disease with complex pathogenesis involves multiple cellular components of the innate and adaptive immune systems, presence of autoantibodies and immune complexes, engagement of the complement system, dysregulation of several cytokines including type I interferons, and… 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
- What is being tested?
- 4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2025to Jan 2028
- Phase
- Interventional
- 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
Who may be able to join
- : Adult SLE Patients ( >18 years ) who are fulfilling the 2019 ACR\EULAR classification criteria of systemic lupus erythematosus
Who cannot join
- SLE patients <18 years old
- Patients with other autoimmune diseases (systemic sclerosis , sjogren syndrome, rheumatoid arthritis dermatomyositis, mixed connective tissue disease).
- Pregnant and lactating women .
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut university hospital
Asyut, Asyut Governorate, 1111
Mai hany ahmed mh Elmorabaa, PHD, 01061371371, mai.elmorabaa@icloud.com
About this study
The SLE is heterogeneous multisystem autoimmune disease with complex pathogenesis involves multiple cellular components of the innate and adaptive immune systems, presence of autoantibodies and immune complexes, engagement of the complement system, dysregulation of several cytokines including type I interferons, and disruption of the clearance of nucleic acids after cell death(1,2,3).
Among the putative mechanisms leading to the pathogenic breakdown of immune tolerance in SLE is the development of auto reactive T Cells, which contribute to pathologic activation of B cells, dysfunction of regulatory T Cells and aberrant production of pro-inflammatory cytokines (4,5) Autoantibodies targeting the T Cell Receptor (TCR)/CD3 have been demonstrated to activate Ca2+/calmodulin-dependent kinase IV (CaMKIV), resulting in diminished IL-2 production and low serum IL-2 levels are commonly observed in SLE (6,7,8,9) T Cell autoantibodies have been shown to influence T Cell signalling, migration, and adhesion, contributing to organ-specific targeting in SLE. These findings suggest that T Cell autoantibodies are active participants in disease pathogenesis and , supporting their potential as biomarkers for diagnosis and disease activity (10) Delays in SLE diagnosis, often due to the limitations of current biomarkers, can lead to worsened outcomes (11). Improved diagnostic markers, such as the T Cell biomarkers described here, could help reduce these delays , improve patient care and improve the ability of clinicians to differentiate between SLE and patients with falsely positive ANA (12) To the best of our knowledge, only a limited number of studies have explored the role of T cell autoantibodies in diagnosing and monitoring disease activity in SLE (12), and none have examined their association with lupus nephritis and disease damage index .
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- 4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by
- 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.
4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) byDiagnostic test
4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by flow cytometry
| Study group | Role | What they receive |
|---|---|---|
| Systemic lupus erythematosus patients | Experimental | 4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by flow cytometry Receives: Diagnostic Test: 4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by |
| Helthy control | Other | 4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by flow cytometry Receives: Diagnostic Test: 4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by |
What is being measured
The primary outcome is the main question the study is designed to answer.
to measure the level of these novel biomarkers and evaluate their role as diagnostic biomarkers in SLE .
Measured: 2 years
Secondary outcomes (1)
Study the correlation of TIgG and TIgM with different SLE manifestations and with disease activity and damage index
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 posted22 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Hany Ahmed Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136337
- Sponsor's protocol ID
- TigG and TigM in SLE
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Utility of T Immunoglobulin G and T Immunoglobulin M Biomarkers in Patients With Systemic Lupus Erythematosus Disease : Associations With Disease Activity and Damage
- ClinicalTrials.gov ID
- NCT07136337
- Acronym / sponsor ID
- TigG and TigM in SLE
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 22 Aug 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.
The SLE is heterogeneous multisystem autoimmune disease with complex pathogenesis involves multiple cellular components of the innate and adaptive immune systems, presence of autoantibodies and immune complexes, engagement of the complement system, dysregulation of several cytokines including type I interferons, and disruption of the clearance of nucleic acids after cell death(1,2,3).
Among the putative mechanisms leading to the pathogenic breakdown of immune tolerance in SLE is the development of auto reactive T Cells, which contribute to pathologic activation of B cells, dysfunction of regulatory T Cells and aberrant production of pro-inflammatory cytokines (4,5) Autoantibodies targeting the T Cell Receptor (TCR)/CD3 have been demonstrated to activate Ca2+/calmodulin-dependent kinase IV (CaMKIV), resulting in diminished IL-2 production and low serum IL-2 levels are commonly observed in SLE (6,7,8,9) T Cell autoantibodies have been shown to influence T Cell signalling, migration, and adhesion, contributing to organ-specific targeting in SLE. These findings suggest that T Cell autoantibodies are active participants in disease pathogenesis and , supporting their potential as biomarkers for diagnosis and disease activity (10) Delays in SLE diagnosis, often due to the limitations of current biomarkers, can lead to worsened outcomes (11). Improved diagnostic markers, such as the T Cell biomarkers described here, could help reduce these delays , improve patient care and improve the ability of clinicians to differentiate between SLE and patients with falsely positive ANA (12) To the best of our knowledge, only a limited number of studies have explored the role of T cell autoantibodies in diagnosing and monitoring disease activity in SLE (12), and none have examined their association with lupus nephritis and disease damage index .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic lupus erythematosus patients | Experimental | Diagnostic Test: 4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by flow cytometry |
| Helthy control | Other | Diagnostic Test: 4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by flow cytometry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- : Adult SLE Patients ( >18 years ) who are fulfilling the 2019 ACR\EULAR classification criteria of systemic lupus erythematosus
Key exclusion criteria (4 listed)
- SLE patients <18 years old
- Patients with other autoimmune diseases (systemic sclerosis , sjogren syndrome, rheumatoid arthritis dermatomyositis, mixed connective tissue disease).
- Pregnant and lactating women .
- -
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 |
|---|---|---|
| 4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by flow cytometry | Diagnostic test | Helthy control, Systemic lupus erythematosus patients |
Primary outcome
to measure the level of these novel biomarkers and evaluate their role as diagnostic biomarkers in SLE .
Time frame: 2 years
1 secondary outcome
Study the correlation of TIgG and TIgM with different SLE manifestations and with disease activity and damage index
Time frame: 2 years
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 22 Aug 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 ml. of fresh venous blood will be collected from each patient on EDTA tube and will be used for detection of the following : T cell immunoglobulin G ( TIgG) and T cell immunoglobulin M (TIgM) by in people with Systemic Lupus Erythematosus, run by Assiut 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 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 22 Aug 2025. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to measure the level of these novel biomarkers and evaluate their role as diagnostic biomarkers in 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?
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 Aug 2025.