ImmunosuppressionNCT02776111
Microfluidics and Transcriptomics in Post Solid Organ Transplant Patients
An observational study of Immunosuppression, run by University of Florida at 1 site in United States.
Trial summary
The field of genomics is an exciting new field being applied in medicine. Its use in treating some cancers, sepsis and burn patients has been very promising. As knowledge of genomics and application of microarrays expands, researchers are developing more intelligent ways to provide individualized care for patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunosuppression
- What is being tested?
- Blood Sample
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 26 Jun 2019
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Controls and Kidney Transplant Patients
Who may be able to join
- Healthy Controls
- consent for blood draw
- Kidney Transplant Group
- actively listed with the University of Florida Kidney Transplant Program (which has its own standards for active listing including not being pregnant),
- consent for blood draw
Who cannot join
- Healthy Control
- pregnancy,
- any known organ failure
- Kidney Transplant Group
- none, exclusive to what is listed in inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Microfluidics and Transcriptomics to Implement Precision Medicine in Post Solid Organ Transplant Patients
The field of genomics is an exciting new field being applied in medicine. Its use in treating some cancers, sepsis and burn patients has been very promising. As knowledge of genomics and application of microarrays expands, researchers are developing more intelligent ways to provide individualized care for patients. The plan of this research study is to apply the use of genomics as a tool for transplant in several capacities.
This research study is designed to develop methods of isolating relevant cell types via microarray plates, then extracting mRNA samples of those cell types and capturing their genetic profile. This will be done with the blood of up to ten healthy donors. Once this ability has been demonstrated, the next step will be to use these testing in several capacities in transplant patients. The research study plan involves following the genetic profile of 26 kidney transplant patients. One group will be followed prospectively starting at baseline, and then at various set time points. A second group will be sampled with the occurrence of clinical events. These events include viral, bacterial, and fungal infection, WBC < 2.5 or biopsy proven rejection episodes or normal graft function. Thus, the intention of the study is to demonstrate how immunosuppression alters the expression of this genetic expression of these T cells. In doing so, the study will provide a better understanding of the specific and true immunosuppressed state for any given patient.
Read the detailed description
The two specific aims of the research study are as follows: 1) Proof of concept with two parts. Firstly, the study plan is to prove that T cells that are very commonly involved in the immune response: CD2, CD3, CD4, and CD8 populations can be captured. These cells will be captured, lysed and their mRNA genomics will be mapped. The second part of the proof of concept will involve exposing the CD2, CD3, CD4 and CD8 populations ex vivo to various serum concentrations of tacrolimus - the main cornerstone immunosuppressive medication in solid organ transplant. Exposure of the three cell types to the various tacrolimus concentrations will demonstrate that there is testing that can detect mRNA transcripts corresponding to under, optimal and over immunosuppressed states. The quantify IL2 production of the three cell types under the various immunosuppressive conditions will then be measured. With these 2 parts of the first specific aim of the study, a technique that can readily and easily isolate the cell populations of interest from the transplant patients and can capture how these cell populations respond to immunosuppression at various concentrations will have been demonstrated. 2) The second specific aim of the research study is running this genomic profiling on kidney transplant recipients. For this portion of the study, there will be two cohorts. A cohort identified as the "prospective" group and a cohort labeled as the "event" group. For the prospective cohort, blood will be obtained from the patients at specific time points. Specifically, blood samples will be obtained in the pre-transplant setting when the patients present to the hospital for their transplant, then at post-kidney transplant day 0, 1, 2, 3 and 7 (+/- 1 day) and at day 14, 21, and 28 (+/-3 days). Blood samples will be obtained again at months 2, 3, 6, 9, and 12 (+/- 1 week ). For the second group, blood samples will be obtained at the time of "events", such as rejection, infection, etc., and apply the same series of tests to their blood. For this group, blood draws will be done at time 0(+/-1 day), at then at one week (+/-2 days), and at one, two and three months (+/-1 week) post time 0. There will be five blood samples collected per patient. For all patients, there will be a comparison of the standard collected clinical information on the patient - graft function, rejection, infection, immunosuppression levels - to the results of our transcriptomics. The culmination of the project will involve revealing how genomics of the specific types of T cells can more precisely reflect a patient's true immunosuppressed state by corresponding to high, optimal and low immunosuppressive clinical phenotypes, and thus allow transplant clinicians to more intelligently and accurately administer immunosuppressive medications.
This study will involve obtaining blood samples on the kidney transplant patients at the time in which they would otherwise have blood collected for standard clinical care. Consent will be obtained for the testing on their blood, but the patients will not suffer any additional pain or inconvenience of the testing. In coordination with the equipment and supplies currently being used by the trauma and critical care department's research, the investigators will organize the collection and running of the labs in a time efficient and minimally expensive way
- Conditions
- Immunosuppression
- Being tested
- Blood Sample
- Keywords
- Kidney Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SampleOther
A one time blood sample will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Participants in this group will have a one time blood sample taken. Receives: Other: Blood Sample | |
| Kidney Transplant Group | Participants in this group have had a kidney transplant and blood samples will be obtained as described in study plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomics of the T-cells will be compared to the immunosuppressed state of kidney transplant patient.
Standard collected clinical information of patients will identify over, optimal and under immunosuppressive states (IS) in kidney transplant (txp) recipients. In txp care, the definition of IS is defined by the clinical picture of the patient. Patients who have infections are over immunosuppressed, patients who have rejection are under immunosuppressed. Patients with neither and good graft function with normal Cr \& good urine output have optimal IS. The investigators hope to identify a genomic pattern of the mRNA of T cells that correlates with the clinical picture of over, under or optimal IS in a kidney txp patient. Blood will be collected at the time of the events \& genomics will be run on the T cell mRNA from that blood of each type of patient. The specific T cell used (CD3, CD4 or CD8) will be determined by the proof of concept portion of the study. The investigators will update this portion of the study as this information is obtained after the proof of concept is completed.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startJul 2016
- Primary completion25 Jun 2019
- Study completion26 Jun 2019
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for ImmunosuppressionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Zarrinpar, MD, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776111
- Sponsor's protocol ID
- IRB201600231
- Status last verified
- Jun 2019
- First submitted
- 16 May 2016
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Antoniades CG, Berry PA, Wendon JA, Vergani D. The importance of immune dysfunction in determining outcome in acute liver failure. J Hepatol. 2008 Nov;49(5):845-61. doi: 10.1016/j.jhep.2008.08.009. Epub 2008 Aug 21.
PubMed 18801592Benitez C, Lozano JJ, Fueyo AS. Gene expression profiling and transplantation tolerance in the clinic. Transplantation. 2009 Aug 15;88(3 Suppl):S50-3. doi: 10.1097/TP.0b013e3181af7d17.
PubMed 19667962Brouard S, Mansfield E, Braud C, Li L, Giral M, Hsieh SC, Baeten D, Zhang M, Ashton-Chess J, Braudeau C, Hsieh F, Dupont A, Pallier A, Moreau A, Louis S, Ruiz C, Salvatierra O, Soulillou JP, Sarwal M. Identification of a peripheral blood transcriptional biomarker panel associated with operational renal allograft tolerance. Proc Natl Acad Sci U S A. 2007 Sep 25;104(39):15448-53. doi: 10.1073/pnas.0705834104. Epub 2007 Sep 14.
PubMed 17873064Bruls T, Gyapay G, Petit JL, Artiguenave F, Vico V, Qin S, Tin-Wollam AM, Da Silva C, Muselet D, Mavel D, Pelletier E, Levy M, Fujiyama A, Matsuda F, Wilson R, Rowen L, Hood L, Weissenbach J, Saurin W, Heilig R. A physical map of human chromosome 14. Nature. 2001 Feb 15;409(6822):947-8. doi: 10.1038/35057177.
PubMed 11237018Cuenca AG, Gentile LF, Lopez MC, Ungaro R, Liu H, Xiao W, Seok J, Mindrinos MN, Ang D, Baslanti TO, Bihorac A, Efron PA, Cuschieri J, Warren HS, Tompkins RG, Maier RV, Baker HV, Moldawer LL; Inflammation and Host Response to Injury Collaborative Research Program. Development of a genomic metric that can be rapidly used to predict clinical outcome in severely injured trauma patients. Crit Care Med. 2013 May;41(5):1175-85. doi: 10.1097/CCM.0b013e318277131c.
PubMed 23388514de Jonge J, Kurian S, Shaked A, Reddy KR, Hancock W, Salomon DR, Olthoff KM. Unique early gene expression patterns in human adult-to-adult living donor liver grafts compared to deceased donor grafts. Am J Transplant. 2009 Apr;9(4):758-72. doi: 10.1111/j.1600-6143.2009.02557.x.
PubMed 19353763Ding R, Li B, Muthukumar T, Dadhania D, Medeiros M, Hartono C, Serur D, Seshan SV, Sharma VK, Kapur S, Suthanthiran M. CD103 mRNA levels in urinary cells predict acute rejection of renal allografts. Transplantation. 2003 Apr 27;75(8):1307-12. doi: 10.1097/01.TP.0000064210.92444.B5.
PubMed 12717221Feezor RJ, Oberholzer C, Baker HV, Novick D, Rubinstein M, Moldawer LL, Pribble J, Souza S, Dinarello CA, Ertel W, Oberholzer A. Molecular characterization of the acute inflammatory response to infections with gram-negative versus gram-positive bacteria. Infect Immun. 2003 Oct;71(10):5803-13. doi: 10.1128/IAI.71.10.5803-5813.2003.
PubMed 14500502Feezor RJ, Baker HV, Mindrinos M, Hayden D, Tannahill CL, Brownstein BH, Fay A, MacMillan S, Laramie J, Xiao W, Moldawer LL, Cobb JP, Laudanski K, Miller-Graziano CL, Maier RV, Schoenfeld D, Davis RW, Tompkins RG; Inflammation and Host Response to Injury, Large-Scale Collaborative Research Program. Whole blood and leukocyte RNA isolation for gene expression analyses. Physiol Genomics. 2004 Nov 17;19(3):247-54. doi: 10.1152/physiolgenomics.00020.2004.
PubMed 15548831Feezor RJ, Cheng A, Paddock HN, Baker HV, Moldawer LL. Functional genomics and gene expression profiling in sepsis: beyond class prediction. Clin Infect Dis. 2005 Nov 15;41 Suppl 7:S427-35. doi: 10.1086/431993.
PubMed 16237642Gentile LF, Cuenca AG, Efron PA, Ang D, Bihorac A, McKinley BA, Moldawer LL, Moore FA. Persistent inflammation and immunosuppression: a common syndrome and new horizon for surgical intensive care. J Trauma Acute Care Surg. 2012 Jun;72(6):1491-501. doi: 10.1097/TA.0b013e318256e000.
PubMed 22695412Hassan-Montero L, Bueno P, Olmedo C, Comino AM, Muffak-Granero K, Garcia-Alcalde F, Serradilla M, Villar JM, Garrote D, Blanco A, Ferron JA. Gene expression profiling in liver transplant recipients with alcoholic cirrhosis. Transplant Proc. 2008 Nov;40(9):2955-8. doi: 10.1016/j.transproceed.2008.08.085.
PubMed 19010158Heller RA, Schena M, Chai A, Shalon D, Bedilion T, Gilmore J, Woolley DE, Davis RW. Discovery and analysis of inflammatory disease-related genes using cDNA microarrays. Proc Natl Acad Sci U S A. 1997 Mar 18;94(6):2150-5. doi: 10.1073/pnas.94.6.2150.
PubMed 9122163Huang Q, Liu D, Majewski P, Schulte LC, Korn JM, Young RA, Lander ES, Hacohen N. The plasticity of dendritic cell responses to pathogens and their components. Science. 2001 Oct 26;294(5543):870-5. doi: 10.1126/science.294.5543.870.
PubMed 11679675Huskey J, Gralla J, Wiseman AC. Single time point immune function assay (ImmuKnow) testing does not aid in the prediction of future opportunistic infections or acute rejection. Clin J Am Soc Nephrol. 2011 Feb;6(2):423-9. doi: 10.2215/CJN.04210510. Epub 2010 Nov 18.
PubMed 21088287
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Microfluidics and Transcriptomics to Implement Precision Medicine in Post Solid Organ Transplant Patients
- ClinicalTrials.gov ID
- NCT02776111
- Acronym / sponsor ID
- IRB201600231
- Conditions
- Immunosuppression
- Keywords
- Kidney Transplant
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 18 May 2016 (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.
The field of genomics is an exciting new field being applied in medicine. Its use in treating some cancers, sepsis and burn patients has been very promising. As knowledge of genomics and application of microarrays expands, researchers are developing more intelligent ways to provide individualized care for patients. The plan of this research study is to apply the use of genomics as a tool for transplant in several capacities.
This research study is designed to develop methods of isolating relevant cell types via microarray plates, then extracting mRNA samples of those cell types and capturing their genetic profile. This will be done with the blood of up to ten healthy donors. Once this ability has been demonstrated, the next step will be to use these testing in several capacities in transplant patients. The research study plan involves following the genetic profile of 26 kidney transplant patients. One group will be followed prospectively starting at baseline, and then at various set time points. A second group will be sampled with the occurrence of clinical events. These events include viral, bacterial, and fungal infection, WBC < 2.5 or biopsy proven rejection episodes or normal graft function. Thus, the intention of the study is to demonstrate how immunosuppression alters the expression of this genetic expression of these T cells. In doing so, the study will provide a better understanding of the specific and true immunosuppressed state for any given patient.
Detailed description
The two specific aims of the research study are as follows: 1) Proof of concept with two parts. Firstly, the study plan is to prove that T cells that are very commonly involved in the immune response: CD2, CD3, CD4, and CD8 populations can be captured. These cells will be captured, lysed and their mRNA genomics will be mapped. The second part of the proof of concept will involve exposing the CD2, CD3, CD4 and CD8 populations ex vivo to various serum concentrations of tacrolimus - the main cornerstone immunosuppressive medication in solid organ transplant. Exposure of the three cell types to the various tacrolimus concentrations will demonstrate that there is testing that can detect mRNA transcripts corresponding to under, optimal and over immunosuppressed states. The quantify IL2 production of the three cell types under the various immunosuppressive conditions will then be measured. With these 2 parts of the first specific aim of the study, a technique that can readily and easily isolate the cell populations of interest from the transplant patients and can capture how these cell populations respond to immunosuppression at various concentrations will have been demonstrated. 2) The second specific aim of the research study is running this genomic profiling on kidney transplant recipients. For this portion of the study, there will be two cohorts. A cohort identified as the "prospective" group and a cohort labeled as the "event" group. For the prospective cohort, blood will be obtained from the patients at specific time points. Specifically, blood samples will be obtained in the pre-transplant setting when the patients present to the hospital for their transplant, then at post-kidney transplant day 0, 1, 2, 3 and 7 (+/- 1 day) and at day 14, 21, and 28 (+/-3 days). Blood samples will be obtained again at months 2, 3, 6, 9, and 12 (+/- 1 week ). For the second group, blood samples will be obtained at the time of "events", such as rejection, infection, etc., and apply the same series of tests to their blood. For this group, blood draws will be done at time 0(+/-1 day), at then at one week (+/-2 days), and at one, two and three months (+/-1 week) post time 0. There will be five blood samples collected per patient. For all patients, there will be a comparison of the standard collected clinical information on the patient - graft function, rejection, infection, immunosuppression levels - to the results of our transcriptomics. The culmination of the project will involve revealing how genomics of the specific types of T cells can more precisely reflect a patient's true immunosuppressed state by corresponding to high, optimal and low immunosuppressive clinical phenotypes, and thus allow transplant clinicians to more intelligently and accurately administer immunosuppressive medications.
This study will involve obtaining blood samples on the kidney transplant patients at the time in which they would otherwise have blood collected for standard clinical care. Consent will be obtained for the testing on their blood, but the patients will not suffer any additional pain or inconvenience of the testing. In coordination with the equipment and supplies currently being used by the trauma and critical care department's research, the investigators will organize the collection and running of the labs in a time efficient and minimally expensive way
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Other: Blood SampleParticipants in this group will have a one time blood sample taken. |
| Kidney Transplant Group | – | –Participants in this group have had a kidney transplant and blood samples will be obtained as described in study plan |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Controls and Kidney Transplant Patients
Key inclusion criteria (5 listed)
- Healthy Controls
- consent for blood draw
- Kidney Transplant Group
- actively listed with the University of Florida Kidney Transplant Program (which has its own standards for active listing including not being pregnant),
- consent for blood draw
Key exclusion criteria (5 listed)
- Healthy Control
- pregnancy,
- any known organ failure
- Kidney Transplant Group
- none, exclusive to what is listed in inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood SampleA one time blood sample will be provided. | Other | Healthy Controls |
Primary outcome
Genomics of the T-cells will be compared to the immunosuppressed state of kidney transplant patient.
Time frame: 12 months
Standard collected clinical information of patients will identify over, optimal and under immunosuppressive states (IS) in kidney transplant (txp) recipients. In txp care, the definition of IS is defined by the clinical picture of the patient. Patients who have infections are over immunosuppressed, patients who have rejection are under immunosuppressed. Patients with neither and good graft function with normal Cr \& good urine output have optimal IS. The investigators hope to identify a genomic pattern of the mRNA of T cells that correlates with the clinical picture of over, under or optimal IS in a kidney txp patient. Blood will be collected at the time of the events \& genomics will be run on the T cell mRNA from that blood of each type of patient. The specific T cell used (CD3, CD4 or CD8) will be determined by the proof of concept portion of the study. The investigators will update this portion of the study as this information is obtained after the proof of concept is completed.
Results and safety
The study was stopped early (reason given: Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Background: PubMed 18801592Antoniades CG, Berry PA, Wendon JA, Vergani D. The importance of immune dysfunction in determining outcome in acute liver failure. J Hepatol. 2008 Nov;49(5):845-61. doi: 10.1016/j.jhep.2008.08.009. Epub 2008 Aug 21.
- Background: PubMed 19667962Benitez C, Lozano JJ, Fueyo AS. Gene expression profiling and transplantation tolerance in the clinic. Transplantation. 2009 Aug 15;88(3 Suppl):S50-3. doi: 10.1097/TP.0b013e3181af7d17.
- Background: PubMed 17873064Brouard S, Mansfield E, Braud C, Li L, Giral M, Hsieh SC, Baeten D, Zhang M, Ashton-Chess J, Braudeau C, Hsieh F, Dupont A, Pallier A, Moreau A, Louis S, Ruiz C, Salvatierra O, Soulillou JP, Sarwal M. Identification of a peripheral blood transcriptional biomarker panel associated with operational renal allograft tolerance. Proc Natl Acad Sci U S A. 2007 Sep 25;104(39):15448-53. doi: 10.1073/pnas.0705834104. Epub 2007 Sep 14.
- Background: PubMed 11237018Bruls T, Gyapay G, Petit JL, Artiguenave F, Vico V, Qin S, Tin-Wollam AM, Da Silva C, Muselet D, Mavel D, Pelletier E, Levy M, Fujiyama A, Matsuda F, Wilson R, Rowen L, Hood L, Weissenbach J, Saurin W, Heilig R. A physical map of human chromosome 14. Nature. 2001 Feb 15;409(6822):947-8. doi: 10.1038/35057177.
- Background: PubMed 23388514Cuenca AG, Gentile LF, Lopez MC, Ungaro R, Liu H, Xiao W, Seok J, Mindrinos MN, Ang D, Baslanti TO, Bihorac A, Efron PA, Cuschieri J, Warren HS, Tompkins RG, Maier RV, Baker HV, Moldawer LL; Inflammation and Host Response to Injury Collaborative Research Program. Development of a genomic metric that can be rapidly used to predict clinical outcome in severely injured trauma patients. Crit Care Med. 2013 May;41(5):1175-85. doi: 10.1097/CCM.0b013e318277131c.
- Background: PubMed 19353763de Jonge J, Kurian S, Shaked A, Reddy KR, Hancock W, Salomon DR, Olthoff KM. Unique early gene expression patterns in human adult-to-adult living donor liver grafts compared to deceased donor grafts. Am J Transplant. 2009 Apr;9(4):758-72. doi: 10.1111/j.1600-6143.2009.02557.x.
- Background: PubMed 12717221Ding R, Li B, Muthukumar T, Dadhania D, Medeiros M, Hartono C, Serur D, Seshan SV, Sharma VK, Kapur S, Suthanthiran M. CD103 mRNA levels in urinary cells predict acute rejection of renal allografts. Transplantation. 2003 Apr 27;75(8):1307-12. doi: 10.1097/01.TP.0000064210.92444.B5.
- Background: PubMed 14500502Feezor RJ, Oberholzer C, Baker HV, Novick D, Rubinstein M, Moldawer LL, Pribble J, Souza S, Dinarello CA, Ertel W, Oberholzer A. Molecular characterization of the acute inflammatory response to infections with gram-negative versus gram-positive bacteria. Infect Immun. 2003 Oct;71(10):5803-13. doi: 10.1128/IAI.71.10.5803-5813.2003.
- Background: PubMed 15548831Feezor RJ, Baker HV, Mindrinos M, Hayden D, Tannahill CL, Brownstein BH, Fay A, MacMillan S, Laramie J, Xiao W, Moldawer LL, Cobb JP, Laudanski K, Miller-Graziano CL, Maier RV, Schoenfeld D, Davis RW, Tompkins RG; Inflammation and Host Response to Injury, Large-Scale Collaborative Research Program. Whole blood and leukocyte RNA isolation for gene expression analyses. Physiol Genomics. 2004 Nov 17;19(3):247-54. doi: 10.1152/physiolgenomics.00020.2004.
- Background: PubMed 16237642Feezor RJ, Cheng A, Paddock HN, Baker HV, Moldawer LL. Functional genomics and gene expression profiling in sepsis: beyond class prediction. Clin Infect Dis. 2005 Nov 15;41 Suppl 7:S427-35. doi: 10.1086/431993.
- Background: PubMed 22695412Gentile LF, Cuenca AG, Efron PA, Ang D, Bihorac A, McKinley BA, Moldawer LL, Moore FA. Persistent inflammation and immunosuppression: a common syndrome and new horizon for surgical intensive care. J Trauma Acute Care Surg. 2012 Jun;72(6):1491-501. doi: 10.1097/TA.0b013e318256e000.
- Background: PubMed 19010158Hassan-Montero L, Bueno P, Olmedo C, Comino AM, Muffak-Granero K, Garcia-Alcalde F, Serradilla M, Villar JM, Garrote D, Blanco A, Ferron JA. Gene expression profiling in liver transplant recipients with alcoholic cirrhosis. Transplant Proc. 2008 Nov;40(9):2955-8. doi: 10.1016/j.transproceed.2008.08.085.
- Individual participant dataSharing planned: No
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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.
Ali Zarrinpar, MD, PhD principal investigator
University of Florida
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 Immunosuppression, run by University of Florida 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 1 Jul 2019. 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 stopped early (reason given: Funding). Results are not available in the source record.
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?
Genomics of the T-cells will be compared to the immunosuppressed state of kidney transplant patient. (time frame: 12 months). 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 NCT02776111, which also lists 45 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 1 Jul 2019.