Clinical trial NCT00861159: RLIP76 in Human Serum in Adults With Rheumatologic Diseases
Official title: Measurement Of RLIP76 Auto Antibodies in Human Serum In Adults With Rheumatologic Diseases.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Carotid Atherosclerosis
Keywords: RLIP76 Auto Antibodies
Lead sponsor: University of North Texas Health Science Center
Sponsor class: OTHER
First posted: 2009-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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).

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.

Primary outcomes:
measure: The focus of the present study is limited to establishing validated protocols for detection of anti-RLIP76 antibodies in human sera.
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: University of North Texas Health Science Center
state: Texas
Study officials:
affiliation: University of North Texas Health Science Center
name: Sanjay Awasthi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Singhal SS, Yadav S, Singhal J, Zajac E, Awasthi YC, Awasthi S. Depletion of RLIP76 sensitizes lung cancer cells to doxorubicin. Biochem Pharmacol. 2005 Aug 1;70(3):481-8. doi: 10.1016/j.bcp.2005.05.005.
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citation: Laemmli UK. Cleavage of structural proteins during the assembly of the head of bacteriophage T4. Nature. 1970 Aug 15;227(5259):680-5. doi: 10.1038/227680a0. No abstract available.
citation: Towbin H, Staehelin T, Gordon J. Electrophoretic transfer of proteins from polyacrylamide gels to nitrocellulose sheets: procedure and some applications. Proc Natl Acad Sci U S A. 1979 Sep;76(9):4350-4. doi: 10.1073/pnas.76.9.4350.
citation: Stuckler D, Singhal J, Singhal SS, Yadav S, Awasthi YC, Awasthi S. RLIP76 transports vinorelbine and mediates drug resistance in non-small cell lung cancer. Cancer Res. 2005 Feb 1;65(3):991-8.