Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-09 @ 6:29 PM
Study NCT ID:
NCT00861159
Status:
WITHDRAWN
Last Update Posted:
2011-01-12
First Post:
2008-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RLIP76 in Human Serum in Adults With Rheumatologic Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'whyStopped': 'Study withdrawn due to lack of staffing resources and subject interest', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-01-11', 'studyFirstSubmitDate': '2008-09-29', 'studyFirstSubmitQcDate': '2009-03-12', 'lastUpdatePostDateStruct': {'date': '2011-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['RLIP76 Auto Antibodies'], 'conditions': ['Carotid Atherosclerosis']}, 'referencesModule': {'references': [{'pmid': '17993611', 'type': 'RESULT', 'citation': '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': '15950949', 'type': 'RESULT', '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.'}, {'pmid': '7503400', 'type': 'RESULT', '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. doi: 10.1111/j.1398-9995.1995.tb02581.x.'}, {'pmid': '1749920', 'type': 'RESULT', 'citation': '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': '942051', 'type': 'RESULT', '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. doi: 10.1016/0003-2697(76)90527-3. No abstract available.'}, {'pmid': '5432063', 'type': 'RESULT', '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.'}, {'pmid': '388439', 'type': 'RESULT', '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.'}, {'pmid': '15705900', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': '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").', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The experimental populations subject to study will be 100 outpatients in the rheumatology clinic otherwise undergoing routinely scheduled phlebotomy for standard clinical care purposes.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (age 18+), non-pregnant subjects with previously diagnosed rheumatologic disease will be candidates for the study.\n\nExclusion Criteria:\n\n* Children, pregnant women, prisoner, persons with any medical condition that precludes phlebotomy, and patients unwilling or unable to provide consent.'}, 'identificationModule': {'nctId': 'NCT00861159', 'briefTitle': 'RLIP76 in Human Serum in Adults With Rheumatologic Diseases', 'organization': {'class': 'OTHER', 'fullName': 'University of North Texas Health Science Center'}, 'officialTitle': 'Measurement Of RLIP76 Auto Antibodies in Human Serum In Adults With Rheumatologic Diseases.', 'orgStudyIdInfo': {'id': '2008-31'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1'}]}, 'contactsLocationsModule': {'locations': [{'zip': '76109', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'University of North Texas Health Science Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Sanjay Awasthi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Texas Health Science Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Texas Health Science Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Measurement of RLIP76 Auto Antibodies in Human Serum in Adults with Rheumatologic Disease.', 'oldOrganization': 'University of North Texas Health Science Center'}}}}