RLIP76 in Human Serum in Adults With Rheumatologic Diseases | NCT00861159

Studies
RLIP76 in Human Serum in Adults With Rheumatologic Diseases

NCT00861159

Sponsor

University of North Texas Health Science Center

Status

Withdrawn

Last Update Posted

Jan 12, 2011Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Carotid Atherosclerosis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2011

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study withdrawn due to lack of staffing resources and subject interest

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Sep 2011Estimated

Completion Date

Sep 2011Estimated

First Submitted Date

Sep 29, 2008

First Submission Date that Met QC Criteria

Mar 12, 2009

First Posted Date

Mar 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2011

Last Update Posted Date

Jan 12, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

It is the investigators aim to determine the feasibility of directly detecting anti-RLIP76 auto-antibodies in human serum using prepared RLIP76 antigen peptides in persons with rheumatologic disease and persons without rheumatologic diesease ("healthy subjects").

Detailed Description

This is an exploratory study conducted to see the feasibility of measuring the anti-RLIP76 antibody and to standardize the methods for its measurement. We will perform these studies on blood samples obtained from human subjects after informed concent for blood draw for research purposes is obtained by the Clinical Research Co-ordinator (CRC).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Label	Type	Description	Intervention Names
1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The focus of the present study is limited to establishing validated protocols for detection of anti-RLIP76 antibodies in human sera.		three years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult (age 18+), non-pregnant subjects with previously diagnosed rheumatologic disease will be candidates for the study.

Exclusion Criteria:

Children, pregnant women, prisoner, persons with any medical condition that precludes phlebotomy, and patients unwilling or unable to provide consent.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The experimental populations subject to study will be 100 outpatients in the rheumatology clinic otherwise undergoing routinely scheduled phlebotomy for standard clinical care purposes.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sanjay Awasthi, MD	University of North Texas Health Science Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of North Texas Health Science Center		Fort Worth	Texas	76109	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17993611	Result	Margutti P, Matarrese P, Conti F, Colasanti T, Delunardo F, Capozzi A, Garofalo T, Profumo E, Rigano R, Siracusano A, Alessandri C, Salvati B, Valesini G, Malorni W, Sorice M, Ortona E. Autoantibodies to the C-terminal subunit of RLIP76 induce oxidative stress and endothelial cell apoptosis in immune-mediated vascular diseases and atherosclerosis. Blood. 2008 May 1;111(9):4559-70. doi: 10.1182/blood-2007-05-092825. Epub 2007 Nov 9.
15950949

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases