AntiDFS70 Lupus Nephritis

NCT ID: NCT06119763

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-15

Study Completion Date

2024-10-25

Brief Summary

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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)

Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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group A

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

anti dfs70 antibodies

Intervention Type DIAGNOSTIC_TEST

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

anti dfs70 antibodies

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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anti dfs70 antibodies

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ashrakat Shabaan Mohamed

resident at rheumatology and rehabilitation department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ashrakat s Mohammed, resident

Role: CONTACT

01005046015

Essam m abo el fadl, professor

Role: CONTACT

Facility Contacts

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Magdy M Amin, professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 19136143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24504808 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14184513 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22556106 (View on PubMed)

Other Identifiers

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Soh-Med-23-10-011MS

Identifier Type: -

Identifier Source: org_study_id

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