Molecular Mechanisms Characteristics in Systemic Lupus Erythematous Autoimmune Disease

Systemic Lupus Erythematosus Clinical Trial

— SLE  

Official title:

Immune Deregulation in Patients With SLE

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02270710
• Other study ID #: 1311014560
• Status: Withdrawn
• Phase: N/A
• First received: October 16, 2014
• Last updated: May 23, 2017
• Start date: April 2013
• Est. completion date: October 2016

Study information

• Verified date: May 2017
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It is well known that the deregulation of immune responses plays a major role in many autoimmune diseases, such as Systemic Lupus Erythematosus (SLE). The main objective of this protocol is to determine whether the expression and/or function of specific molecules are deregulated in the immune cells of patients with SLE. By examining IRF4, IRF5, IBP/Def6, SWAP-70, Rock1, Rock2, and specific signaling molecules involved in the responsiveness to sex hormones, the investigators hypothesize that the deregulation in the expression and function of these molecules will result in abnormalities in the functioning of the immune cells, which is a key factor in autoimmunity.

Peripheral blood lymphocytes from healthy controls and patients with SLE will be collected and compared in order to determine if specific immune cells (IL-17 and IL-21) are deregulated in patients with SLE and if this deregulation affects their functioning. Specifically, immune cells will be isolated from the blood and then subject to scientific testing (QPCR, Western blotting, immunofluorescence assays, ELISA and FACS analysis) to see if the expression and function of these cells is related to the mechanism behind SLE. This will be a case control study, where cases of SLE will be compared to controls of healthy volunteers to assess risk factors. As these healthy volunteers are providing samples solely for research purposes, there is no standard of care for these volunteers, with the exception of a positive HIV result during screening. The Department of Genetic Medicine will enroll healthy controls and the Hospital for Special Surgery will enroll subjects with Systemic Lupus Erythematosus (SLE) for a comparative analysis of the two cohorts. Laboratory testing on all blood samples will be done at the Hospital for Special Surgery.

Description:

This will be a case control study, where cases of SLE will be compared to controls of healthy volunteers to assess risk factors. As these healthy volunteers are providing samples solely for research purposes, there is no standard of care for these volunteers, with the exception of a positive HIV result during screening. The Department of Genetic Medicine will enroll healthy controls and the Hospital for Special Surgery will enroll subjects with Systemic Lupus Erythematosus (SLE) for a comparative analysis of the two cohorts (Table I). Laboratory testing on all blood samples will be done at the Hospital for Special Surgery.

Table I. Site Recruitment1

WCMC Healthy Subjects 20 HSS Subjects with SLE 20 Total 40

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Must provide informed consent

• Males and females, age 18 years and older

• Healthy Nonsmokers

Exclusion Criteria:

If the subject has

• Rheumatic disease

• Diabetes

• SLE or lupus

• Autoimmune disease

• Active infection or pregnancy

• HIV infection

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Locations

Country	Name	City	State
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the molecules that play a role in onset of SLE and autoimmune disease	Immune cells isolated from blood samples of healthy and SLE subjects IRF4, IRF5, IBP/Def6, SWAP-70, Rock1, Rock2 molecules expression examined through scientific testing (QPCR, Western blotting, immunofluorescence assays, ELISA and FACS analysis)	1 year