AntiDFS70 Lupus Nephritis

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06119763
Collaborator
(none)
50
1
12.4
4

Study Details

Study Description

Brief Summary

Systemic lupus erythematous (SLE) is a heterogeneous autoimmune disease that involve many different organs and display a variable clinical course. The prevalence of SLE varies across gender, race/ethnicity, and geographic regions. SLE demonstrates a striking female predominance with a peak incidence of disease during the Reproductive years. In adults, the female to male ratio is 10- 15:1(1)( 2)

Clinical features in individual patients can be quite variable and range from mild joint and skin involvement to severe, life-threatening internal organ disease. Constitutional symptoms, rash, mucosal ulcers, inflammatory polyarthritis, photosensitivity, and serositis are the most common clinical features of the disease. (3) (4) Anti-DFS70 antibodie) and their clinical associations remain an immunological paradox. Unlike other antinuclear antibodies , there is a growing body of evidence that anti-DFS70 antibodies, when present in high titers and in isolation (without accompanying other antibodies), are useful to aid in the exclusion of antinuclear antibodies associated rheumatic diseases. (8)

Anti-DFS70 antibodies were not associated with lupus nephritis development in Systemic lupus erythematosus patients but were associated with anti-dsDNA antibodies , proliferative lupus nephritis, and renal activity index . This suggests their potential to serve as a non-histological biomarker for lupus nephritis subclass and activity status. (8)

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: anti dfs70 antibodies

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Anti-DFS70 Antibodies and it's Relationship With Systemic Lupus Erythematosus Manifestations
Actual Study Start Date :
Oct 15, 2023
Anticipated Primary Completion Date :
Oct 15, 2024
Anticipated Study Completion Date :
Oct 25, 2024

Arms and Interventions

Arm Intervention/Treatment
group A

systemic lupus erythematosus cases, diagnosed by SLICC criteria with negative levels of AntiDFS antibodies

Diagnostic Test: anti dfs70 antibodies
blood sample is taken from SLE cases and is tested for antiDFS70 antibodies titre

group B

systemic lupus erythematosus cases, diagnosed by SLICC criteria with positive levels of AntiDFS antibodies

Diagnostic Test: anti dfs70 antibodies
blood sample is taken from SLE cases and is tested for antiDFS70 antibodies titre

Outcome Measures

Primary Outcome Measures

  1. antiDFS70 antibodies titre [1 year]

    serve as a non-histological biomarker for lupus nephritis subclass and activity status.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  1. Patients who fulfill the 2019 American College of Rheumatology/European League against Rheumatism classification criteria of Systemic Lupus Erythematous . (9)

  2. Patients who is able to give informed consent to join the study.

Exclusion Criteria:
  • Any patient with any collagen disease other than systemic lupus erythematous

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag university Hospital Sohag Egypt Sohag

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ashrakat Shabaan Mohamed, resident at rheumatology and rehabilitation department, Sohag University
ClinicalTrials.gov Identifier:
NCT06119763
Other Study ID Numbers:
  • Soh-Med-23-10-011MS
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2023