Carotid AtherosclerosisNCT00861159
RLIP76 in Human Serum in Adults With Rheumatologic Diseases
An observational study of Carotid Atherosclerosis, run by University of North Texas Health Science Center at 1 site in United States.
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"). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Carotid Atherosclerosis
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- Adult (age 18+), non-pregnant subjects with previously diagnosed rheumatologic disease will be candidates for the study.
Who cannot join
- Children, pregnant women, prisoner, persons with any medical condition that precludes phlebotomy, and patients unwilling or unable to provide consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Texas Health Science Center
Fort Worth, Texas, 76109
About this study
Official title: Measurement Of RLIP76 Auto Antibodies in Human Serum In Adults With Rheumatologic Diseases.
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").
Read the 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).
- Conditions
- Carotid Atherosclerosis
- Keywords
- RLIP76 Auto Antibodies
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The focus of the present study is limited to establishing validated protocols for detection of anti-RLIP76 antibodies in human sera.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startSep 2011
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Why it stopped: Study withdrawn due to lack of staffing resources and subject interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Investigators
- Sanjay Awasthi, MD, Principal investigator, University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861159
- Sponsor's protocol ID
- 2008-31
- Status last verified
- Jan 2011
- First submitted
- 29 Sep 2008
- Last updated
- 12 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17993611Singhal 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.
PubMed 15950949Huang 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.
PubMed 7503400Boyum 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.
PubMed 1749920Bradford 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.
PubMed 942051Laemmli 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.
PubMed 5432063Towbin 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.
PubMed 388439Stuckler 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.
PubMed 15705900
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement Of RLIP76 Auto Antibodies in Human Serum In Adults With Rheumatologic Diseases.
- ClinicalTrials.gov ID
- NCT00861159
- Acronym / sponsor ID
- 2008-31
- Conditions
- Carotid Atherosclerosis
- Keywords
- RLIP76 Auto Antibodies
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to lack of staffing resources and subject interest
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- Adult (age 18+), non-pregnant subjects with previously diagnosed rheumatologic disease will be candidates for the study.
Key exclusion criteria (1 listed)
- Children, pregnant women, prisoner, persons with any medical condition that precludes phlebotomy, and patients unwilling or unable to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The focus of the present study is limited to establishing validated protocols for detection of anti-RLIP76 antibodies in human sera.
Time frame: three years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2011.
- Results publication: PubMed 17993611Margutti 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.
- Results publication: PubMed 15950949Singhal 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.
- Results publication: PubMed 7503400Huang 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.
- Results publication: PubMed 1749920Boyum 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.
- Results publication: PubMed 942051Bradford 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.
- Results publication: PubMed 5432063Laemmli 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.
- Results publication: PubMed 388439Towbin 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.
- Results publication: PubMed 15705900Stuckler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Awasthi, MD principal investigator
University of North Texas Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Atherosclerosis, run by University of North Texas Health Science Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The focus of the present study is limited to establishing validated protocols for detection of anti-RLIP76 antibodies in human sera. (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00861159, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2011.