NCT06151990

Brief Summary

. To determine pattern and frequency of dyslipoproteinemia in patients with newly diagnosed juvenile SLE and to assess effect of disease activity on lipid profile of patients with juvenile SLE.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

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 13, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

November 30, 2023

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

November 13, 2023

Last Update Submit

November 21, 2023

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

  • lipid profile

    pattern and frequency of dyslipoproteinemia in patients with newly diagnosed JSLE .

    2 years

  • lipid profile

    effect of disease activity on lipid profile of patients with JSLE

    2 years

Study Arms (3)

newly diagnosed juvenile systemic lupus erythematosus

Other: lipid profile

old cases of juvenile systemic lupus in activity

Other: lipid profile

old cases of juvenile systemic lupus not in activity(controlled)

Other: lipid profile

Interventions

lipid profileOTHER

Measurements for CHOL,TG,LDL-C and HDL-C obtained following an overnight fasting

newly diagnosed juvenile systemic lupus erythematosusold cases of juvenile systemic lupus in activityold cases of juvenile systemic lupus not in activity(controlled)

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

.Patients diagnosed with jSLE between 5 and 18 years of age

You may qualify if:

  • Patients who are diagnosed according to 2019 European League against Rheumatism (EULAR) /American College of Rheumatology (ACR) SLE classification criteria .
  • Patients diagnosed with jSLE between 5 and 18 years of age

You may not qualify if:

  • \. Patients on lipid lowering drugs for any other reason. 2. Patients with other autoimmune disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

RECRUITING

Related Publications (4)

  • Sarkissian T, Beyene J, Feldman B, McCrindle B, Silverman ED. Longitudinal examination of lipid profiles in pediatric systemic lupus erythematosus. Arthritis Rheum. 2007 Feb;56(2):631-8. doi: 10.1002/art.22332.

    PMID: 17265498BACKGROUND

  • Tyrrell PN, Beyene J, Benseler SM, Sarkissian T, Silverman ED. Predictors of lipid abnormalities in children with new-onset systemic lupus erythematosus. J Rheumatol. 2007 Oct;34(10):2112-9. Epub 2007 Sep 1.

    PMID: 17787042BACKGROUND

  • Machado D, Sarni RO, Abad TT, Silva SG, Khazaal EJ, Hix S, Correia MS, Suano-Souza FI, Len CA, Terreri MT. Lipid profile among girls with systemic lupus erythematosus. Rheumatol Int. 2017 Jan;37(1):43-48. doi: 10.1007/s00296-015-3393-z. Epub 2015 Nov 16.

    PMID: 26573664BACKGROUND

  • Rodrigues WDR, Sarni ROS, Abad TTO, Silva SGLD, Souza FIS, Len CA, Terreri MT. Lipid profile of pediatric patients with chronic rheumatic diseases - a retrospective analysis. Rev Assoc Med Bras (1992). 2020 Aug;66(8):1093-1099. doi: 10.1590/1806-9282.66.8.1093.

    PMID: 32935804BACKGROUND

Related Links

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jaafar I Mohamad, professor

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Naglaa S Mohamad, lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Yosra M Mamdouh, lecturer

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara A Mahmoud, resident

CONTACT

+02-01144250777saraabdelnassermahmoud1997@gmail.com

Jaafar I Mohamad, professor

CONTACT

+02-01020627864Gafaribrahim2015@aun.edu.eg

Study Design

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

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 30, 2023

Study Start

December 1, 2023

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

November 30, 2023

Record last verified: 2023-09

Locations

EG(1)