NCT00861159

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").

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2008

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
2.5 years until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 12, 2011

Status Verified

January 1, 2011

Enrollment Period

Same day

First QC Date

September 29, 2008

Last Update Submit

January 11, 2011

Conditions

Carotid Atherosclerosis

Keywords

RLIP76 Auto Antibodies

Outcome Measures

Primary Outcomes (1)

  • The focus of the present study is limited to establishing validated protocols for detection of anti-RLIP76 antibodies in human sera.

    three years

Study Arms (1)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Texas Health Science Center

Fort Worth, Texas, 76109, United States

Location

Related Publications (8)

  • 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.

    PMID: 17993611RESULT

  • 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.

    PMID: 15950949RESULT

  • Huang X, Johansson SG, Zargari A, Nordvall SL. Allergen cross-reactivity between Pityrosporum orbiculare and Candida albicans. Allergy. 1995 Aug;50(8):648-56. doi: 10.1111/j.1398-9995.1995.tb02581.x.

    PMID: 7503400RESULT

  • Boyum A, Lovhaug D, Tresland L, Nordlie EM. Separation of leucocytes: improved cell purity by fine adjustments of gradient medium density and osmolality. Scand J Immunol. 1991 Dec;34(6):697-712. doi: 10.1111/j.1365-3083.1991.tb01594.x.

    PMID: 1749920RESULT

  • Bradford MM. A rapid and sensitive method for the quantitation of microgram quantities of protein utilizing the principle of protein-dye binding. Anal Biochem. 1976 May 7;72:248-54. doi: 10.1016/0003-2697(76)90527-3. No abstract available.

    PMID: 942051RESULT

  • 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.

    PMID: 5432063RESULT

  • 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.

    PMID: 388439RESULT

  • 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.

    PMID: 15705900RESULT

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sanjay Awasthi, MD

    University of North Texas Health Science Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2008

First Posted

March 13, 2009

Study Start

September 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 12, 2011

Record last verified: 2011-01

Locations

US(1)