SLE (Systemic Lupus)NCT06063668
Autotaxin as Abiomarker in Systemic Lupus Erythematosus Patients
An observational study of SLE (Systemic Lupus), run by Assiut University.
Trial summary
Estimation of the serum ATX level in SLE patients in comparison to healthy subjects. Evaluation of the relation of serum ATX level with disease activity and different clinical manifestation in SLE patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SLE (Systemic Lupus)
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Oct 2025
- 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 75 years
- All sexes
- Adult, Older adult
Study population: SLE patients fullfilling the 2012 systemic lupus international collaborating clinics (SLICC) criteria ,older than 18 years old with no other rheumatic diseases or malignancy. Controls are healthy controls .
Who may be able to join
- Patients who will be diagnosed as SLE according to the 2012 systemic lupus international collaborating clinics (SLICC) criteria .
- SLE Patients older than 18 years old.
Who cannot join
- SLE Patients younger than 18 years old.
- Patients with other rheumatic diseases or overlap syndromes.
- Patients with malignancy.
- Patients with chronic hepatitis C.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Serum Autotaxin as a Potential Biomarker in Systemic Lupus Erythematosus Patients and Its Relation to Disease Activity.
- Estimation of the serum ATX level in SLE patients in comparison to healthy subjects.
- Evaluation of the relation of serum ATX level with disease activity and different clinical manifestation in SLE patients
Read the detailed description
Systemic lupus erythematosus (SLE) is a chronic multisystem autoimmune inflammatory disease with unknown etiology . However, several genetic, immunological and environmental factors play a role in the etiopathogenesis of SLE . During the disease course, patients may be presented with diverse clinical manifestations (mucocutaneous, articular, neurological, or renal manifestations) . Anti-nuclear antibodies(ANA), anti- double stranded DNA (ds-DNA)and anti smith(SM) antibodies are common biomarkers of SLE. However the sensitivity and specificity of the current biomarkers are not ideal that the diagnosis of SLE can be missed .
Lysophospholipids are phospholipids with only one fatty acid chain, such as lysophosphatidic acid (LPA) and lysophosphatidylserine. Autotaxin (ATX), one of the enzymes that catalyze the formation of Lysophospholipid, is mainly responsible for the production of LPA in blood . Tumor necrosis factor (TNF), interleukin-6 (IL-6), and type I interferons, have been reported to induce the expression of ATX . ATX was reported recently as potential biomarkers of various diseases (serum ATX in malignancy and chronic hepatitis C, while in acute myocardial infarction ATX was overexpressed in cardiac tissue and in the synovium of rheumatoid arthritis patients) . Several studies have reported that serum ATX concentrations were higher in females than in males . The mRNA expression of ATX was found to be significantly induced by estrogen . There is growing evidence that ATX may play a role in the pathogenesis of SLE. Few recent studies have reported that serum ATX level can be a possible novel biomarker and key molecule in SLE .
- Conditions
- SLE (Systemic Lupus)
- 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 |
|---|---|---|
| patients | SLE patients | |
| controls | healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum ATX level in SLE patients in comparison to healthy controls.
Measure ATX level in serum of sle patients and compare it with ATX level in serum of healthy controls.
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 posted2 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for SLE (Systemic Lupus)Studies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mohamed Abd-Elrazik Ahmed, Assiut University
- Investigators
- Nada Mohamed Gamal Abd-Elaleem, Ass. Prof, Study chair, Assiut UniversityMaha Sayed Ibrahim Abdelrahman, Lecturer, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063668
- Sponsor's protocol ID
- Autotaxin in sle
- Status last verified
- Oct 2023
- First submitted
- 24 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tsuchida Y, Shoda H, Sawada T, Fujio K. Role of autotaxin in systemic lupus erythematosus. Front Med (Lausanne). 2023 Apr 4;10:1166343. doi: 10.3389/fmed.2023.1166343. eCollection 2023.
PubMed 37122329Tsuchida Y, Shoda H, Nakano M, Ota M, Okamura T, Yamamoto K, Kurano M, Yatomi Y, Fujio K, Sawada T. Autotaxin is a potential link between genetic risk factors and immunological disturbances of plasmacytoid dendritic cells in systematic lupus erythematosus. Lupus. 2022 Nov;31(13):1578-1585. doi: 10.1177/09612033221128494. Epub 2022 Sep 22.
PubMed 36134766Cojocaru M, Cojocaru IM, Silosi I, Vrabie CD. Manifestations of systemic lupus erythematosus. Maedica (Bucur). 2011 Oct;6(4):330-6.
PubMed 22879850Magkrioti C, Galaris A, Kanellopoulou P, Stylianaki EA, Kaffe E, Aidinis V. Autotaxin and chronic inflammatory diseases. J Autoimmun. 2019 Nov;104:102327. doi: 10.1016/j.jaut.2019.102327. Epub 2019 Aug 28.
PubMed 31471142Iwata Y, Kitajima S, Yamahana J, Shimomura S, Yoneda-Nakagawa S, Sakai N, Furuichi K, Ogura H, Sato K, Toyama T, Yamamura Y, Miyagawa T, Hara A, Shimizu M, Ohkawa R, Kurano M, Yatomi Y, Wada T. Higher serum levels of autotaxin and phosphatidylserine-specific phospholipase A1 in patients with lupus nephritis. Int J Rheum Dis. 2021 Feb;24(2):231-239. doi: 10.1111/1756-185X.14031. Epub 2020 Dec 11.
PubMed 33314787Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.
PubMed 11838846Tan EM. Antinuclear antibodies: diagnostic markers for autoimmune diseases and probes for cell biology. Adv Immunol. 1989;44:93-151. doi: 10.1016/s0065-2776(08)60641-0. No abstract available.
PubMed 2646863Yu H, Nagafuchi Y, Fujio K. Clinical and Immunological Biomarkers for Systemic Lupus Erythematosus. Biomolecules. 2021 Jun 22;11(7):928. doi: 10.3390/biom11070928.
PubMed 34206696Masuda A, Nakamura K, Izutsu K, Igarashi K, Ohkawa R, Jona M, Higashi K, Yokota H, Okudaira S, Kishimoto T, Watanabe T, Koike Y, Ikeda H, Kozai Y, Kurokawa M, Aoki J, Yatomi Y. Serum autotaxin measurement in haematological malignancies: a promising marker for follicular lymphoma. Br J Haematol. 2008 Oct;143(1):60-70. doi: 10.1111/j.1365-2141.2008.07325.x. Epub 2008 Aug 15.
PubMed 18710386Tokuhara Y, Kurano M, Shimamoto S, Igarashi K, Nojiri T, Kobayashi T, Masuda A, Ikeda H, Nagamatsu T, Fujii T, Aoki J, Yatomi Y. A New Enzyme Immunoassay for the Quantitative Determination of Classical Autotaxins (ATXalpha, ATXbeta, and ATXgamma) and Novel Autotaxins (ATXdelta and ATXepsilon). PLoS One. 2015 Jun 17;10(6):e0130074. doi: 10.1371/journal.pone.0130074. eCollection 2015.
PubMed 26083365Zhang G, Cheng Y, Zhang Q, Li X, Zhou J, Wang J, Wei L. ATX-LPA axis facilitates estrogen-induced endometrial cancer cell proliferation via MAPK/ERK signaling pathway. Mol Med Rep. 2018 Mar;17(3):4245-4252. doi: 10.3892/mmr.2018.8392. Epub 2018 Jan 8.
PubMed 29328374Petri M, Orbai AM, Alarcon GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sanchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Fang H, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473.
PubMed 22553077Stoll T, Seifert B, Isenberg DA. SLICC/ACR Damage Index is valid, and renal and pulmonary organ scores are predictors of severe outcome in patients with systemic lupus erythematosus. Br J Rheumatol. 1996 Mar;35(3):248-54. doi: 10.1093/rheumatology/35.3.248.
PubMed 8620300
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Autotaxin as a Potential Biomarker in Systemic Lupus Erythematosus Patients and Its Relation to Disease Activity.
- ClinicalTrials.gov ID
- NCT06063668
- Acronym / sponsor ID
- Autotaxin in sle
- Conditions
- SLE (Systemic Lupus)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 2 Oct 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.
- Estimation of the serum ATX level in SLE patients in comparison to healthy subjects.
- Evaluation of the relation of serum ATX level with disease activity and different clinical manifestation in SLE patients
Detailed description
Systemic lupus erythematosus (SLE) is a chronic multisystem autoimmune inflammatory disease with unknown etiology . However, several genetic, immunological and environmental factors play a role in the etiopathogenesis of SLE . During the disease course, patients may be presented with diverse clinical manifestations (mucocutaneous, articular, neurological, or renal manifestations) . Anti-nuclear antibodies(ANA), anti- double stranded DNA (ds-DNA)and anti smith(SM) antibodies are common biomarkers of SLE. However the sensitivity and specificity of the current biomarkers are not ideal that the diagnosis of SLE can be missed .
Lysophospholipids are phospholipids with only one fatty acid chain, such as lysophosphatidic acid (LPA) and lysophosphatidylserine. Autotaxin (ATX), one of the enzymes that catalyze the formation of Lysophospholipid, is mainly responsible for the production of LPA in blood . Tumor necrosis factor (TNF), interleukin-6 (IL-6), and type I interferons, have been reported to induce the expression of ATX . ATX was reported recently as potential biomarkers of various diseases (serum ATX in malignancy and chronic hepatitis C, while in acute myocardial infarction ATX was overexpressed in cardiac tissue and in the synovium of rheumatoid arthritis patients) . Several studies have reported that serum ATX concentrations were higher in females than in males . The mRNA expression of ATX was found to be significantly induced by estrogen . There is growing evidence that ATX may play a role in the pathogenesis of SLE. Few recent studies have reported that serum ATX level can be a possible novel biomarker and key molecule in SLE .
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | –SLE patients |
| controls | – | –healthy controls |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- SLE patients fullfilling the 2012 systemic lupus international collaborating clinics (SLICC) criteria ,older than 18 years old with no other rheumatic diseases or malignancy. Controls are healthy controls .
Key inclusion criteria (2 listed)
- Patients who will be diagnosed as SLE according to the 2012 systemic lupus international collaborating clinics (SLICC) criteria .
- SLE Patients older than 18 years old.
Key exclusion criteria (4 listed)
- SLE Patients younger than 18 years old.
- Patients with other rheumatic diseases or overlap syndromes.
- Patients with malignancy.
- Patients with chronic hepatitis C.
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 ATX level in SLE patients in comparison to healthy controls.
Time frame: 2 years
Measure ATX level in serum of sle patients and compare it with ATX level in serum of healthy controls.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Results publication: PubMed 37122329Tsuchida Y, Shoda H, Sawada T, Fujio K. Role of autotaxin in systemic lupus erythematosus. Front Med (Lausanne). 2023 Apr 4;10:1166343. doi: 10.3389/fmed.2023.1166343. eCollection 2023.
- Results publication: PubMed 36134766Tsuchida Y, Shoda H, Nakano M, Ota M, Okamura T, Yamamoto K, Kurano M, Yatomi Y, Fujio K, Sawada T. Autotaxin is a potential link between genetic risk factors and immunological disturbances of plasmacytoid dendritic cells in systematic lupus erythematosus. Lupus. 2022 Nov;31(13):1578-1585. doi: 10.1177/09612033221128494. Epub 2022 Sep 22.
- Results publication: PubMed 22879850Cojocaru M, Cojocaru IM, Silosi I, Vrabie CD. Manifestations of systemic lupus erythematosus. Maedica (Bucur). 2011 Oct;6(4):330-6.
- Results publication: PubMed 31471142Magkrioti C, Galaris A, Kanellopoulou P, Stylianaki EA, Kaffe E, Aidinis V. Autotaxin and chronic inflammatory diseases. J Autoimmun. 2019 Nov;104:102327. doi: 10.1016/j.jaut.2019.102327. Epub 2019 Aug 28.
- Results publication: PubMed 33314787Iwata Y, Kitajima S, Yamahana J, Shimomura S, Yoneda-Nakagawa S, Sakai N, Furuichi K, Ogura H, Sato K, Toyama T, Yamamura Y, Miyagawa T, Hara A, Shimizu M, Ohkawa R, Kurano M, Yatomi Y, Wada T. Higher serum levels of autotaxin and phosphatidylserine-specific phospholipase A1 in patients with lupus nephritis. Int J Rheum Dis. 2021 Feb;24(2):231-239. doi: 10.1111/1756-185X.14031. Epub 2020 Dec 11.
- Results publication: PubMed 11838846Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91.
- Results publication: PubMed 2646863Tan EM. Antinuclear antibodies: diagnostic markers for autoimmune diseases and probes for cell biology. Adv Immunol. 1989;44:93-151. doi: 10.1016/s0065-2776(08)60641-0. No abstract available.
- Results publication: PubMed 34206696Yu H, Nagafuchi Y, Fujio K. Clinical and Immunological Biomarkers for Systemic Lupus Erythematosus. Biomolecules. 2021 Jun 22;11(7):928. doi: 10.3390/biom11070928.
- Results publication: PubMed 18710386Masuda A, Nakamura K, Izutsu K, Igarashi K, Ohkawa R, Jona M, Higashi K, Yokota H, Okudaira S, Kishimoto T, Watanabe T, Koike Y, Ikeda H, Kozai Y, Kurokawa M, Aoki J, Yatomi Y. Serum autotaxin measurement in haematological malignancies: a promising marker for follicular lymphoma. Br J Haematol. 2008 Oct;143(1):60-70. doi: 10.1111/j.1365-2141.2008.07325.x. Epub 2008 Aug 15.
- Results publication: PubMed 26083365Tokuhara Y, Kurano M, Shimamoto S, Igarashi K, Nojiri T, Kobayashi T, Masuda A, Ikeda H, Nagamatsu T, Fujii T, Aoki J, Yatomi Y. A New Enzyme Immunoassay for the Quantitative Determination of Classical Autotaxins (ATXalpha, ATXbeta, and ATXgamma) and Novel Autotaxins (ATXdelta and ATXepsilon). PLoS One. 2015 Jun 17;10(6):e0130074. doi: 10.1371/journal.pone.0130074. eCollection 2015.
- Results publication: PubMed 29328374Zhang G, Cheng Y, Zhang Q, Li X, Zhou J, Wang J, Wei L. ATX-LPA axis facilitates estrogen-induced endometrial cancer cell proliferation via MAPK/ERK signaling pathway. Mol Med Rep. 2018 Mar;17(3):4245-4252. doi: 10.3892/mmr.2018.8392. Epub 2018 Jan 8.
- Results publication: PubMed 22553077Petri M, Orbai AM, Alarcon GS, Gordon C, Merrill JT, Fortin PR, Bruce IN, Isenberg D, Wallace DJ, Nived O, Sturfelt G, Ramsey-Goldman R, Bae SC, Hanly JG, Sanchez-Guerrero J, Clarke A, Aranow C, Manzi S, Urowitz M, Gladman D, Kalunian K, Costner M, Werth VP, Zoma A, Bernatsky S, Ruiz-Irastorza G, Khamashta MA, Jacobsen S, Buyon JP, Maddison P, Dooley MA, van Vollenhoven RF, Ginzler E, Stoll T, Peschken C, Jorizzo JL, Callen JP, Lim SS, Fessler BJ, Inanc M, Kamen DL, Rahman A, Steinsson K, Franks AG Jr, Sigler L, Hameed S, Fang H, Pham N, Brey R, Weisman MH, McGwin G Jr, Magder LS. Derivation and validation of the Systemic Lupus International Collaborating Clinics classification criteria for systemic lupus erythematosus. Arthritis Rheum. 2012 Aug;64(8):2677-86. doi: 10.1002/art.34473.
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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.
Nada Mohamed Gamal Abd-Elaleem, Ass. Prof study chair
Assiut University
Maha Sayed Ibrahim Abdelrahman, Lecturer study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of SLE (Systemic Lupus), 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 2 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 3 Oct 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 Mariam Mohamed Abd-Elrazik Ahmed, resident (01009979491, mariammoham36@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum ATX level in SLE patients in comparison to healthy controls. (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 NCT06063668, which also lists 13 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 3 Oct 2023.