Ignite Creation Date:
2024-05-06 @ 3:21 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02270710
Status:
WITHDRAWN
Last Update Posted:
2017-05-24
First Post:
2014-10-16
Brief Title:
Molecular Mechanisms Characteristics in Systemic Lupus Erythematous Autoimmune Disease
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Immune Deregulation in Patients With SLE
Status:
WITHDRAWN
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Research direction changed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLE
Brief 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 andor function of specific molecules are deregulated in the immune cells of patients with SLE By examining IRF4 IRF5 IBPDef6 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
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
Detailed 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
Table I Site Recruitment1
WCMC Healthy Subjects 20 HSS Subjects with SLE 20 Total 40
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None