NCT04558814

Brief Summary

Study aims to evaluate serum galectin-9 in systemic lupus erythematosus patients and determine it's correlation with overall disease process

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

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 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

11 months

First QC Date

September 16, 2020

Last Update Submit

September 23, 2020

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • Evaluate serum galectin-9 level in SLE patients and compare it with the serum galectin-9 level in healthy controls.

    Compare level of galectin-9 in SLE patients with that of healthy controls

    One year

Secondary Outcomes (1)

  • compare galectin-9 in SLE patients with active and inactive renal disease.

    One year

Study Arms (2)

Systemic lupus erythematosus patients

OTHER

Evaluation of serum galectin-9 level

Diagnostic Test: Serum galectin-9 level

Control group

OTHER

Evaluation of serum galectin-9 level

Diagnostic Test: Serum galectin-9 level

Interventions

Serum galectin-9 levelDIAGNOSTIC_TEST

Determining level of galectin-9 in sera of patients of SLE with different disease activity and organ affection and Sera of control group

Control groupSystemic lupus erythematosus patients

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • clinically diagnosed systemic lupus erythematosus patients.

You may not qualify if:

  • Individuals with other autoimmune diseases: 1)rheumatoid arthritis patients 2)dermatomyositis 3)scleroderma 4)mixed connective tissue disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Muslimov IA, Iacoangeli A, Eom T, Ruiz A, Lee M, Stephenson S, Ginzler EM, Tiedge H. Neuronal BC RNA Transport Impairments Caused by Systemic Lupus Erythematosus Autoantibodies. J Neurosci. 2019 Sep 25;39(39):7759-7777. doi: 10.1523/JNEUROSCI.1657-18.2019. Epub 2019 Aug 12.

    PMID: 31405929RESULT

  • Catalina MD, Bachali P, Geraci NS, Grammer AC, Lipsky PE. Gene expression analysis delineates the potential roles of multiple interferons in systemic lupus erythematosus. Commun Biol. 2019 Apr 23;2:140. doi: 10.1038/s42003-019-0382-x. eCollection 2019.

    PMID: 31044165RESULT

  • Kudose S, Santoriello D, Bomback AS, Stokes MB, D'Agati VD, Markowitz GS. Sensitivity and Specificity of Pathologic Findings to Diagnose Lupus Nephritis. Clin J Am Soc Nephrol. 2019 Nov 7;14(11):1605-1615. doi: 10.2215/CJN.01570219. Epub 2019 Oct 25.

    PMID: 31653670RESULT

  • Ronnblom L, Leonard D. Interferon pathway in SLE: one key to unlocking the mystery of the disease. Lupus Sci Med. 2019 Aug 13;6(1):e000270. doi: 10.1136/lupus-2018-000270. eCollection 2019.

    PMID: 31497305RESULT

  • Matta B, Barnes BJ. Coordination between innate immune cells, type I IFNs and IRF5 drives SLE pathogenesis. Cytokine. 2020 Aug;132:154731. doi: 10.1016/j.cyto.2019.05.018. Epub 2019 May 23.

    PMID: 31130331RESULT

  • Brohawn PZ, Streicher K, Higgs BW, Morehouse C, Liu H, Illei G, Ranade K. Type I interferon gene signature test-low and -high patients with systemic lupus erythematosus have distinct gene expression signatures. Lupus. 2019 Nov;28(13):1524-1533. doi: 10.1177/0961203319885447. Epub 2019 Oct 29.

    PMID: 31660791RESULT

  • Matsuoka N, Fujita Y, Temmoku J, Furuya MY, Asano T, Sato S, Matsumoto H, Kobayashi H, Watanabe H, Suzuki E, Kozuru H, Yastuhashi H, Migita K. Galectin-9 as a biomarker for disease activity in systemic lupus erythematosus. PLoS One. 2020 Jan 27;15(1):e0227069. doi: 10.1371/journal.pone.0227069. eCollection 2020.

    PMID: 31986153RESULT

  • Chen HY, Wu YF, Chou FC, Wu YH, Yeh LT, Lin KI, Liu FT, Sytwu HK. Intracellular Galectin-9 Enhances Proximal TCR Signaling and Potentiates Autoimmune Diseases. J Immunol. 2020 Mar 1;204(5):1158-1172. doi: 10.4049/jimmunol.1901114. Epub 2020 Jan 22.

    PMID: 31969388RESULT

  • Vilar KM, Pereira MC, Tavares Dantas A, de Melo Rego MJB, Pitta IDR, Pinto Duarte ALB, da Rocha Pitta MG. Galectin-9 gene (LGALS9) polymorphisms are associated with rheumatoid arthritis in Brazilian patients. PLoS One. 2019 Oct 10;14(10):e0223191. doi: 10.1371/journal.pone.0223191. eCollection 2019.

    PMID: 31600237RESULT

  • 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

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Mona Hussein, Doctor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reem Hossam Abd El-rahman, Master

CONTACT

01033992163medohossamkikii@gmail.com

Essam Ahmed Mohamed abda, Professor

CONTACT

01003889450essamabda@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 22, 2020

Study Start

January 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

September 25, 2020

Record last verified: 2020-09