NCT03752983

Brief Summary

Systemic lupus erythematosus (SLE) is systemic autoimmune disease characterized by various immunological abnormalities, including dysregulated activation of both T and B lymphocytes with overt production of autoreactive antibodies.The chemokine CXC ligand 13 protein (CXCL13), also known as B cell-attracting chemokine-1 (BAC-1) or B lymphocyte chemoattractant (BLC), CXCL13 serum levels were correlated with disease activity using the SLE Disease Activity Index (SLEDAI) and to lupus nephritis

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
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

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

November 22, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 29, 2019

Status Verified

November 1, 2018

Enrollment Period

1 year

First QC Date

November 22, 2018

Last Update Submit

January 27, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • to measure the level of cxcl13 in SLE

    to differentiate the level of (cxcl13) between healthy individuals and patients with SLE

    Baseline

Study Arms (2)

cases

patients with SLE

Diagnostic Test: blood samples

controls

Healthy people

Diagnostic Test: blood samples

Interventions

blood samplesDIAGNOSTIC_TEST

blood samples

casescontrols

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

two groups: 46 patients with SLE 40 healthy people

You may qualify if:

  • SLE patients diagnosed according to ACR

You may not qualify if:

  • patient with other autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ahmadpoor P, Dalili N, Rostami M. An update on pathogenesis of systemic lupus erythematosus. Iran J Kidney Dis. 2014 May;8(3):171-84.

    PMID: 24878938BACKGROUND

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Mariam Mohamed, Master

CONTACT

Wafaa El-Sherif, profeesor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assuit lecturer

Study Record Dates

First Submitted

November 22, 2018

First Posted

November 26, 2018

Study Start

March 1, 2019

Primary Completion

March 1, 2020

Study Completion

December 1, 2020

Last Updated

January 29, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share