NCT06063668

Brief 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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

October 3, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

September 24, 2023

Last Update Submit

October 1, 2023

Conditions

SLE (Systemic Lupus)

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

patients

SLE patients

controls

healthy controls

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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 .

You may qualify if:

  • 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.

You may not qualify if:

  • SLE Patients younger than 18 years old.
  • Patients with other rheumatic diseases or overlap syndromes.
  • Patients with malignancy.
  • Patients with chronic hepatitis C.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 37122329RESULT

  • 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. Lupus. 2022 Nov;31(13):1578-1585. doi: 10.1177/09612033221128494. Epub 2022 Sep 22.

    PMID: 36134766RESULT

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

    PMID: 22879850RESULT

  • 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.

    PMID: 31471142RESULT

  • 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-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.

    PMID: 33314787RESULT

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

    PMID: 11838846RESULT

  • 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.

    PMID: 2646863RESULT

  • 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.

    PMID: 34206696RESULT

  • 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 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.

    PMID: 18710386RESULT

  • 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 Novel Autotaxins (ATXdelta and ATXepsilon). PLoS One. 2015 Jun 17;10(6):e0130074. doi: 10.1371/journal.pone.0130074. eCollection 2015.

    PMID: 26083365RESULT

  • 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.

    PMID: 29328374RESULT

  • 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 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.

    PMID: 22553077RESULT

  • 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/35.3.248.

    PMID: 8620300RESULT

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nada Mohamed Gamal Abd-Elaleem, Ass. Prof

    Assiut University

    STUDY CHAIR

  • Maha Sayed Ibrahim Abdelrahman, Lecturer

    Assiut University

    STUDY CHAIR

Central Study Contacts

Mariam Mohamed Abd-Elrazik Ahmed, resident

CONTACT

01009979491mariammoham36@gmail.com

Zahraa Ibrahim Abou-Eleyoun, Professor

CONTACT

01006408555Zahraa.Selim@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

September 24, 2023

First Posted

October 2, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2025

Last Updated

October 3, 2023

Record last verified: 2023-10