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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00861159
Other study ID # 2008-31
Secondary ID
Status Withdrawn
Phase N/A
First received September 29, 2008
Last updated January 11, 2011
Start date September 2011
Est. completion date September 2011

Study information

Verified date January 2011
Source University of North Texas Health Science Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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").


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).


Recruitment information / eligibility

Status Withdrawn
Enrollment 100
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
United States University of North Texas Health Science Center Fort Worth Texas

Sponsors (1)

Lead Sponsor Collaborator
University of North Texas Health Science Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

Bøyum A, Løvhaug 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. — View Citation

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. — View Citation

Huang X, Johansson SG, Zargari A, Nordvall SL. Allergen cross-reactivity between Pityrosporum orbiculare and Candida albicans. Allergy. 1995 Aug;50(8):648-56. — View Citation

Laemmli UK. Cleavage of structural proteins during the assembly of the head of bacteriophage T4. Nature. 1970 Aug 15;227(5259):680-5. — View Citation

Margutti P, Matarrese P, Conti F, Colasanti T, Delunardo F, Capozzi A, Garofalo T, Profumo E, Riganò 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 s — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The focus of the present study is limited to establishing validated protocols for detection of anti-RLIP76 antibodies in human sera. three years No
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