Autotaxin as Abiomarker in Systemic Lupus Erythematosus Patients

SLE (Systemic Lupus) Clinical Trial

Official title:

Serum Autotaxin as a Potential Biomarker in Systemic Lupus Erythematosus Patients and Its Relation to Disease Activity.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06063668
• Other study ID #: Autotaxin in sle
• Status: Not yet recruiting
• Start date: October 2023
• Est. completion date: October 2025

Study information

• Verified date: October 2023
• Source: Assiut University
• Contact: Mariam Mohamed Abd-Elrazik Ahmed, resident
• Phone: 01009979491
• Email: mariammoham36[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• SLE Patients younger than 18 years old.

• Patients with other rheumatic diseases or overlap syndromes.

• Patients with malignancy.

• Patients with chronic hepatitis C.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• SLE (Systemic Lupus)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (13)

Cojocaru M, Cojocaru IM, Silosi I, Vrabie CD. Manifestations of systemic lupus erythematosus. Maedica (Bucur). 2011 Oct;6(4):330-6. — View Citation

Gladman DD, Ibanez D, Urowitz MB. Systemic lupus erythematosus disease activity index 2000. J Rheumatol. 2002 Feb;29(2):288-91. — View Citation

Iwata 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-speci — View Citation

Magkrioti 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. — View Citation

Masuda 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 — View Citation

Petri 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 — View Citation

Stoll 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/35.3.24 — View Citation

Tan 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. — View Citation

Tokuhara 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 Nove — View Citation

Tsuchida 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 — View Citation

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. — View Citation

Yu H, Nagafuchi Y, Fujio K. Clinical and Immunological Biomarkers for Systemic Lupus Erythematosus. Biomolecules. 2021 Jun 22;11(7):928. doi: 10.3390/biom11070928. — View Citation

Zhang 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years