AntiDFS70 Lupus Nephritis

NCT06119763 | Unknown

• 1 other identifier: Soh-Med-23-10-011MS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• antiDFS70 antibodies titre

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

  1 year

Study Arms (2)

group A

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

Diagnostic Test: anti dfs70 antibodies

group B

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

Diagnostic Test: anti dfs70 antibodies

Interventions

anti dfs70 antibodies DIAGNOSTIC_TEST

blood sample is taken from SLE cases and is tested for antiDFS70 antibodies titre

group A; group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Patients who fulfill the 2019 American College of Rheumatology/European League against Rheumatism classification criteria of Systemic Lupus Erythematous . (9)
• Patients who is able to give informed consent to join the study.

You may not qualify if:

• \- Any patient with any collagen disease other than systemic lupus erythematous

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Sohag, Egypt

RECRUITING

Related Publications (4)

• Pons-Estel GJ, Alarcon GS, Scofield L, Reinlib L, Cooper GS. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum. 2010 Feb;39(4):257-68. doi: 10.1016/j.semarthrit.2008.10.007. Epub 2009 Jan 10.

  PMID: 19136143 BACKGROUND

• Lim SS, Bayakly AR, Helmick CG, Gordon C, Easley KA, Drenkard C. The incidence and prevalence of systemic lupus erythematosus, 2002-2004: The Georgia Lupus Registry. Arthritis Rheumatol. 2014 Feb;66(2):357-68. doi: 10.1002/art.38239.

  PMID: 24504808 BACKGROUND

• DUBOIS EL, TUFFANELLI DL. CLINICAL MANIFESTATIONS OF SYSTEMIC LUPUS ERYTHEMATOSUS. COMPUTER ANALYSIS OF 520 CASES. JAMA. 1964 Oct 12;190:104-11. doi: 10.1001/jama.1964.03070150014003. No abstract available.

  PMID: 14184513 BACKGROUND

• Hahn BH, McMahon MA, Wilkinson A, Wallace WD, Daikh DI, Fitzgerald JD, Karpouzas GA, Merrill JT, Wallace DJ, Yazdany J, Ramsey-Goldman R, Singh K, Khalighi M, Choi SI, Gogia M, Kafaja S, Kamgar M, Lau C, Martin WJ, Parikh S, Peng J, Rastogi A, Chen W, Grossman JM; American College of Rheumatology. American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care Res (Hoboken). 2012 Jun;64(6):797-808. doi: 10.1002/acr.21664. No abstract available.

  PMID: 22556106 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

ashrakat s Mohammed, resident

CONTACT

01005046015; ashraketshaaban@med.sohag.edu.eg

Essam m abo el fadl, professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at rheumatology and rehabilitation department

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: October 15, 2023
• Primary Completion: October 15, 2024
• Study Completion: October 25, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

EG (1)