DR20 DataRelease

SDY614: Mayo Clinic Smallpox Vaccine Immunogenetics Replication Study
Status: New
Description: Smallpox Vaccine Immunogenetics
Program/Contract:
ProgramContract
Population Genetics Analysis Program (2) Population Genetics Analysis Program: Smallpox Vaccine Immunogenetics
DOI: 10.21430/M3EEL6ILMK
Subjects: 1061
Study PI, contact:
NameOrganizationSite
Gregory Poland Mayo Clinic Mayo Clinic
Publications:
Genome-wide association study of antibody response to smallpox vaccine.. Vaccine. Jun 2012. doi: 10.1016/j.vaccine.2012.04.055. Epub 2012 Apr 25. [Pubmed: 22542470]
A large population-based association study between HLA and KIR genotypes and measles vaccine antibody responses.. PLoS One. Feb 2017. doi: 10.1371/journal.pone.0171261. eCollection 2017. [Pubmed: 28158231]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
ELISA 43744
ELISPOT 12288
HLA Typing 1056
Sequencing 108
SNP microarray 6864
Virus Neutralization 2136
Clinical Assessments:None
SDY691: HLA and KIR Haplotype Sequencing
Status: New
Description: Assay development for complete HLA and KIR haplotype sequencing from cell lines
Program/Contract:
ProgramContract
HLA Region Genetics in Immune-mediated Diseases II Insights into immune-related disease born from population genomics
DOI: 10.21430/M3RES1FXTG
Subjects: 97
Study PI, contact:
NameOrganizationSite
Paul Norman Stanford Stanford
Publications:
Defining KIR and HLA Class I Genotypes at Highest Resolution via High-Throughput Sequencing.. Am J Hum Genet. Aug 2016. doi: 10.1016/j.ajhg.2016.06.023. [Pubmed: 27486779]
Sequences of 95 human MHC haplotypes reveal extreme coding variation in genes other than highly polymorphic HLA class I and II.. Genome Res. Mar 2017. doi: 10.1101/gr.213538.116. [Epub ahead of print] [Pubmed: 28360230]
Resources:
NCBI BioProject https://www.ncbi.nlm.nih.gov/bioproject/?term=PRJEB6763]
GitHub https://github.com/n0rmski/projectH]
Assays:
Assay TypeNumber of Exp. Samples
Sequencing 290
Clinical Assessments:None
SDY775: Evaluating differences between healthy placental microbiome and contamination control sample microbiomes
Status: New
Description: Placental samples from healthy deliveries were compared to an extensive set of bacterial contamination controls as well as to oral and vaginal samples from the same women. This control study was unable to distinguish bacterial species and abundance between placental and contamination control samples
Program/Contract:
ProgramContract
March of Dimes March of Dimes Human Microbiome
DOI: 10.21430/M3PZM1ERD2
Subjects: 7
Study PI, contact:
NameOrganizationSite
Frederic Bushman University of Pennsylvania School of Medicine University of Pennsylvania School of Medicine
Publications:
Comparison of placenta samples with contamination controls does not provide evidence for a distinct placenta microbiota.. Microbiome. Jun 2016. doi: 10.1186/s40168-016-0172-3. [Pubmed: 27338728]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
16S rRNA gene sequencing 69
Q-PCR 69
Clinical Assessments:None
SDY820: Human Immune Signature of Mycobacterium Tuberculosis infection. (See SDY1324 for sorted cell gene expression data)
Status: New
Description: The human immune signature of latent Mycobacterium tuberculosis infected patients as well as BCG vaccinated and BCG non-vaccinated individuals was studied by flow cytometry
Program/Contract:
ProgramContract
Human Immunology Project Consortium 2 (HIPC2) Human immune signatures of dengue virus and mycobacterium tuberculosis exposure in infection; disease and vaccination (HIPC2)
DOI: 10.21430/M3D02NOSVH
Subjects: 60
Study PI, contact:
NameOrganizationSite
Bjoern Peters La Jolla Institute for Allergy and Immunology La Jolla Institute for Allergy and Immunology
Publications:
An Integrated Workflow To Assess Technical and Biological Variability of Cell Population Frequencies in Human Peripheral Blood by Flow Cytometry.. J Immunol. Feb 2017. doi: 10.4049/jimmunol.1601750. Epub 2017 Jan 9. [Pubmed: 28069807]
Transcriptomic Analysis of CD4+ T Cells Reveals Novel Immune Signatures of Latent Tuberculosis.. J Immunol. Mar 2018. doi: - [Pubmed: 29602771]
Resources:
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 60
HLA Typing 60
RNA sequencing 85
Clinical Assessments:None
SDY827: An Interactive Reference Framework for Modeling a Dynamic Immune System
Status: New
Description: We leveraged mass cytometry, a platform that allows measurement of multiple parameters simultaneously at the single-cell level, to initiate a reference map of the immune system. By combining the throughput of flow cytometry with the resolution of mass spectrometry, this hybrid technology enables the simultaneous quantification of 40 parameters in single cells. Use of mass cytometry allows fluorophore reporters to be replaced with isotopically-pure, stable heavy metal ions conjugated to antibodies or affinity reagents. These reporter ions are then quantified by time-of-flight mass spectrometry to provide single-cell measurements, enabling a more detailed characterization of complex cellular systems for a robust reference map.
Program/Contract:
ProgramContract
Software and Hardware Inference Engines For Automated Determination Of Primary Cell Function SOFTWARE & HARDWARE INFERENCE ENGINES FOR AUTOMATED DETERMINATION OF PRIMARY CELL FUNCTION
DOI: 10.21430/M3JX1JSOLB
Subjects: 5
Study PI, contact:
NameOrganizationSite
Garry Nolan STANFORD UNIVERSITY STANFORD UNIVERSITY
Publications:
IMMUNOLOGY. An interactive reference framework for modeling a dynamic immune system.. Science. Jul 2015. doi: 10.1126/science.1259425. [Pubmed: 26160952]
Resources:
github https://github.com/nolanlab/MouseImmuneReference]
Assays:
Assay TypeNumber of Exp. Samples
CyTOF 94
Clinical Assessments:None
SDY887: Defective signaling in aging
Status: New
Description: Pilot year. Despite the importance of the immune system in many diseases, there are currently no objective benchmarks of immunological health. In an effort to indentify benchmarks of immunological health, influenza vaccination was used in 10 young (20-30 years) and 19 older subjects (60 to 89 years) as models for strong and weak immune responses, respectively. Serological responses to influenza strains as well as a wide variety of other parameters, including gene expression, antibodies to hemagglutinin peptides, serum cytokines, cell subset phenotypes and in vitro cytokine stimulation were measured. Using machine learning, nine variables predicting antibody response with 84% accuracy were identified. Two of these variables are involved in apoptosis, which positively associated with the response to vaccination and was confirmed to be a contributor to vaccine responsiveness in mice. The identification of these biomarkers provides new insights into what immune features may be most important for immune health.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Vaccination and infection: indicators of immunological health and responsiveness
DOI: 10.21430/M33JMYFLF1
Subjects: 26
Study PI, contact:
NameOrganizationSite
Cornelia Dekker Stanford University Stanford University
Publications:
Defective Signaling in the JAK-STAT Pathway Tracks with Chronic Inflammation and Cardiovascular Risk in Aging Humans.. Cell Syst. Oct 2016. doi: 10.1016/j.cels.2016.09.009. Epub 2016 Oct 13. [Pubmed: 27746093]
Resources:
Department of Pediatrics- Infectious Diseases Stanford University School of Medicine http://med.stanford.edu/pedsid/contact.html]
Shen-Orr Lab, Technion http://shenorrlab.technion.ac.il/]
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 208
Clinical Assessments:None
SDY939: Pathologically expanded peripheral B cell-helper T cells in Rheumatoid Arthritis
Status: New
Description: CD4+ T cells are central mediators of autoimmune pathology; however,
Program/Contract:
ProgramContract
PROSET-HD Profiling of Cell Subsets in Human Disease PROSET-HD Profiling of Cell Subsets in Human Disease
DOI: 10.21430/M3OLBPJIB1
Subjects: 4
Study PI, contact:
NameOrganizationSite
Michael Brenner Division of Rheumatology, Immunology, and Allergy, Brigham and Womens Hospital and Harvard Medical School Brigham and Women's Hospital
Publications:
Pathologically expanded peripheral T helper cell subset drives B cells in rheumatoid arthritis.. Nature. Feb 2017. doi: 10.1038/nature20810. [Pubmed: 28150777]
Resources:
Brigham and Women's Hospital http://brighamandwomens.org]
NCBI GEO https://ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE80253]
Assays:
Assay TypeNumber of Exp. Samples
RNA sequencing 64
Clinical Assessments:
Clinical Disease Activity Index (CDAI)
SDY91: Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis (RAVE ITN021AI)
Status: Updated
Description:

Current conventional therapies for ANCA-associated vasculitis (AAV) are associated with high incidences of treatment failure, disease relapse, substantial toxicity, and patient morbidity and mortality. Rituximab is a monoclonal antibody used to treat non-Hodgkin's lymphoma. This study will evaluate the efficacy of rituximab with glucocorticoids in inducing disease remission in patients with severe forms of AAV (WG and MPA).

The study consists of two phases: a 6-month remission induction phase, followed by a 12-month remission maintenance phase. All participants will receive at least 1 g of pulse intravenous methylprednisolone or a dose-equivalent of another glucocorticoid preparation. Depending on the participant's condition, he or she may receive up to 3 days of intravenous methylprednisolone for a total of 3 g of methylprednisolone (or a dose-equivalent). During the remission induction phase, all participants will receive oral prednisone daily (1 mg/kg/day, not to exceed 80 mg/day). Prednisone tapering will be completed by the Month 6 study visit.

Participants will then be randomly assigned to one of two arms. Arm 1 participants will receive rituximab (375 mg/m^2) infusions once weekly for 4 weeks and cyclophosphamide (CYC) placebo daily for 3 to 6 months. Arm 2 participants will receive rituximab placebo infusions once weekly for 4 weeks and CYC daily for 3 to 6 months. During the remission maintenance phase, participants in Arm 1 will discontinue CYC placebo and start oral azathioprine (AZA) placebo daily until Month 18. Participants in Arm 2 will discontinue CYC and start AZA daily until Month 18. Participants who fail treatment before Month 6 will be crossed over to the other treatment arm unless there are specific contraindications. Participants in either group who reach clinical remission before they complete 6 months of therapy may switch from CYC/placebo to AZA/placebo if directed by their physicians.All participants will be followed for at least 18 months. Initially, study visits are weekly, progressing to monthly and then quarterly visits as the study proceeds. Blood collection will occur at each study visit.

Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis (RAVE), Immune Tolerance Network
DOI: 10.21430/M3TK42R0QR
Subjects: 197
Study PI, contact:
NameOrganizationSite
Ulrich Specks Mayo Clinic Mayo Clinic
John H. Stone Johns Hopkins University Johns Hopkins University
Publications:
Rituximab versus cyclophosphamide for ANCA-associated vasculitis.. N Engl J Med. Jul 2010. doi: 10.1056/NEJMoa0909905. [Pubmed: 20647199]
Circulating markers of vascular injury and angiogenesis in antineutrophil cytoplasmic antibody-associated vasculitis.. Arthritis Rheum. Dec 2011. doi: 10.1002/art.30615. [Pubmed: 21953143]
Circulating angiopoietin-2 as a biomarker in ANCA-associated vasculitis.. PLoS One. - 2012. doi: 10.1371/journal.pone.0030197. Epub 2012 Jan 18. [Pubmed: 22279570]
Efficacy of remission-induction regimens for ANCA-associated vasculitis.. N Engl J Med. Aug 2013. doi: 10.1056/NEJMoa1213277. [Pubmed: 23902481]
Pro: Should all patients with anti-neutrophil cytoplasmic antibody-associated vasculitis be primarily treated with rituximab?. Nephrol Dial Transplant. Jul 2015. doi: 10.1093/ndt/gfv217. Epub 2015 May 21. [Pubmed: 25999375]
Reanalysis of the Rituximab in ANCA-Associated Vasculitis trial identifies granulocyte subsets as a novel early marker of successful treatment.. Arthritis Res Ther. Sep 2015. doi: 10.1186/s13075-015-0778-z. [Pubmed: 26387933]
Design of the Rituximab in ANCA-associated Vasculitis (RAVE) Trial.. The Open Arthritis Journal Nov 2011. doi: 10.2174/1876539401104010001 [Pubmed: TBD_A]
Resources:
ImmuneTolerance.org http://www.immunetolerance.org/]
ImmuneTolerance.org https://www.itntrialshare.org/]
Clinicaltrials.gov http://clinicaltrials.gov/ct2/show/NCT00104299]
The Open Arthritis Journal https://www.immunetolerance.org/sites/files/2011.11%20OpenArthritisJournal_Specks%20%28RAVE%20Design%29.pdf]
Assays:
Assay TypeNumber of Exp. Samples
ELISA 1175
Flow Cytometry 1151
Clinical Assessments:
Assignment
Baseline Height (cm)
Baseline Weight (kg)
BVAS/WG
Diagnosis
Flares
Prednisone Taper
Remission
SF-36
Vasculitis Damage Index
SDY212: Apoptosis and other immune biomarkers predict influenza vaccine (TIV 2008) responsiveness
Status: Updated
Description: Despite the importance of the immune system in many diseases, there are currently no objective benchmarks of immunological health. In an effort to indentify benchmarks of immunological health, influenza vaccination was used in 30 young (20-30 years) and 59 older subjects (60 to 89 years) as models for strong and weak immune responses, respectively. Serological responses to influenza strains as well as a wide variety of other parameters, including gene expression, antibodies to hemagglutinin peptides, serum cytokines, cell subset phenotypes and in vitro cytokine stimulation were measured. Using machine learning, nine variables predicting antibody response with 84% accuracy were identified. Two of these variables are involved in apoptosis, which positively associated with the response to vaccination and was confirmed to be a contributor to vaccine responsiveness in mice. The identification of these biomarkers provides new insights into what immune features may be most important for immune health.
Program/Contract:
ProgramContract
Human Immunology Project Consortium 1 (HIPC1) Vaccination and infection: indicators of immunological health and responsiveness
DOI: 10.21430/M37NGTHMDS
Subjects: 91
Study PI, contact:
NameOrganizationSite
Mark M. Davis Stanford University Stanford-LPCH Vaccine Program
Publications:
Apoptosis and other immune biomarkers predict influenza vaccine responsiveness.. Mol Syst Biol. Apr 2013. doi: 10.1038/msb.2013.15. [Pubmed: 23591775]
Effects of aging, cytomegalovirus infection, and EBV infection on human B cell repertoires.. J Immunol. Jan 2014. doi: 10.4049/jimmunol.1301384. Epub 2013 Dec 11. [Pubmed: 24337376]
Defective Signaling in the JAK-STAT Pathway Tracks with Chronic Inflammation and Cardiovascular Risk in Aging Humans.. Cell Syst. Oct 2016. doi: 10.1016/j.cels.2016.09.009. Epub 2016 Oct 13. [Pubmed: 27746093]
Resources:
Gene Expression Omnibus (GEO) http://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE41080]
Assays:
Assay TypeNumber of Exp. Samples
Flow Cytometry 1086
Hemagglutination Inhibition 534
Luminex xMAP 91
Protein microarray 91
Transcription profiling by array 91
Clinical Assessments:None
SDY289: Live Kidney Donor Study (RELIVE-01)
Status: Updated
Description: The purpose of this study was to establish a multi-center kidney donor database containing renal failure, cardiovascular and overall mortality information for the complete cohorts of kidney donors who underwent living donor uninephrectomy.
Program/Contract:
ProgramContract
RELIVE CLINICAL OUTCOMES OF LIVE ORGAN DONORS - DATA COORDINATING CENTER
DOI: 10.21430/M3DM0S6FPM
Subjects: 8922
Study PI, contact:
NameOrganizationSite
Sandra Taler Division of Nephrology and Hypertension, Mayo Clinic Mayo Clinic
Publications:
Living donor age and kidney transplant outcomes.. Am J Transplant. Jun 2011. doi: 10.1111/j.1600-6143.2011.03552.x. Epub 2011 May 12. [Pubmed: 21564530]
Demographic, metabolic, and blood pressure characteristics of living kidney donors spanning five decades.. Am J Transplant. Feb 2013. doi: 10.1111/j.1600-6143.2012.04321.x. Epub 2012 Nov 8. [Pubmed: 23137211]
Health-related quality of life in kidney donors from the last five decades: results from the RELIVE study.. Am J Transplant. Nov 2013. doi: 10.1111/ajt.12434. Epub 2013 Sep 6. [Pubmed: 24011252]
Satisfaction With Life Among Living Kidney Donors: A RELIVE Study of Long-Term Donor Outcomes.. Transplantation. Dec 2014. doi: 10.1097/TP.0000000000000360. [Pubmed: 25136843]
Emotional well-being of living kidney donors: findings from the RELIVE Study.. Am J Transplant. Nov 2014. doi: 10.1111/ajt.12906. Epub 2014 Oct 7. [Pubmed: 25293374]
Emotional and Financial Experiences of Kidney Donors over the Past 50 Years: The RELIVE Study.. Clin J Am Soc Nephrol. Dec 2015. doi: 10.2215/CJN.07120714. Epub 2015 Oct 13. [Pubmed: 26463883]
Resources:
Clinicaltrials.gov http://www.clinicaltrials.gov/ct2/show/NCT00608283]
NIH RePORTER http://projectreporter.nih.gov/project_info_details.cfm?aid=7099092&icde=26162432]
Assays:None
Clinical Assessments:None
SDY290: Live Kidney Donor Study - Cross-Sectional and Historical Cohort Study (RELIVE-04)
Status: Updated
Description: The goal of this study is to determine the long-term risks of donor nephrectomy, compared to appropriate control subjects. This study built on information generated from RELIVE-01, a separate but related retrospective study. Through direct contact with previous living kidney donors this study examined the contribution of living kidney donation to the future development of hypertension, proteinuria, renal insufficiency or renal failure and anemia, the potential through these factors or others for increased cardiovascular risk for clinical events including myocardial infarction (MI), congestive heart failure (CHF), need for coronary artery bypass grafting (CABG) or percutaneous coronary angioplasty (PTCA) revascularization, and the impact of living kidney donation on quality of life (QOL) and financial status, compared to applicable control subjects and populations.
Program/Contract:
ProgramContract
RELIVE CLINICAL OUTCOMES OF LIVE ORGAN DONORS - DATA COORDINATING CENTER
DOI: 10.21430/M39RJDHJVB
Subjects: 196
Study PI, contact:
NameOrganizationSite
Sandra Taler Division of Nephrology and Hypertension, Mayo Clinic Mayo Clinic
Publications:
Living donor age and kidney transplant outcomes.. Am J Transplant. Jun 2011. doi: 10.1111/j.1600-6143.2011.03552.x. Epub 2011 May 12. [Pubmed: 21564530]
Demographic, metabolic, and blood pressure characteristics of living kidney donors spanning five decades.. Am J Transplant. Feb 2013. doi: 10.1111/j.1600-6143.2012.04321.x. Epub 2012 Nov 8. [Pubmed: 23137211]
Health-related quality of life in kidney donors from the last five decades: results from the RELIVE study.. Am J Transplant. Nov 2013. doi: 10.1111/ajt.12434. Epub 2013 Sep 6. [Pubmed: 24011252]
Satisfaction With Life Among Living Kidney Donors: A RELIVE Study of Long-Term Donor Outcomes.. Transplantation. Dec 2014. doi: 10.1097/TP.0000000000000360. [Pubmed: 25136843]
Emotional well-being of living kidney donors: findings from the RELIVE Study.. Am J Transplant. Nov 2014. doi: 10.1111/ajt.12906. Epub 2014 Oct 7. [Pubmed: 25293374]
Emotional and Financial Experiences of Kidney Donors over the Past 50 Years: The RELIVE Study.. Clin J Am Soc Nephrol. Dec 2015. doi: 10.2215/CJN.07120714. Epub 2015 Oct 13. [Pubmed: 26463883]
Resources:
Clinicaltrials.gov http://www.clinicaltrials.gov/ct2/show/study/NCT00951977]
NIH RePORTER http://projectreporter.nih.gov/project_info_details.cfm?aid=7099092&icde=26162432]
Assays:None
Clinical Assessments:None
SDY291: Live Kidney Donor Study -Renal Function Study (RELIVE-06)
Status: Updated
Description: As part of a cross-sectional study of living kidney donors from 5 to more than 50 years following donor nephrectomy, this study's goal is to accurately measure current Glomerular Filtration Rate (GFR), then to look at the change in GFR from pre to post donation and from early to late time points after donation. This study builds on information generated from RELIVE-01 and RELIVE-04. Through direct contact with previous living kidney donors, this study aims to quantify changes in renal function (measured GFR) from pre to early post donation using data already collected in a related retrospective study (RELIVE 01), and the change in renal function from early (in the first 2 years) post donation to late (beyond the first 2 years) post donation by repeating a GFR measurement. Cross-sectional GFR measurements from black donors compared to white donors matched for age, sex, weight and time from donation will provide data on differences in GFR late after donor nephrectomy by race. When compared to GFR estimates using predictive equations at each of these time points, we can evaluate the accuracy of estimated GFR in white and black donor populations.
Program/Contract:
ProgramContract
RELIVE CLINICAL OUTCOMES OF LIVE ORGAN DONORS - DATA COORDINATING CENTER
DOI: 10.21430/M33MG60QVQ
Subjects: 413
Study PI, contact:
NameOrganizationSite
Sandra Taler Division of Nephrology and Hypertension, Mayo Clinic Mayo Clinic
Publications:
Living donor age and kidney transplant outcomes.. Am J Transplant. Jun 2011. doi: 10.1111/j.1600-6143.2011.03552.x. Epub 2011 May 12. [Pubmed: 21564530]
Demographic, metabolic, and blood pressure characteristics of living kidney donors spanning five decades.. Am J Transplant. Feb 2013. doi: 10.1111/j.1600-6143.2012.04321.x. Epub 2012 Nov 8. [Pubmed: 23137211]
Health-related quality of life in kidney donors from the last five decades: results from the RELIVE study.. Am J Transplant. Nov 2013. doi: 10.1111/ajt.12434. Epub 2013 Sep 6. [Pubmed: 24011252]
Satisfaction With Life Among Living Kidney Donors: A RELIVE Study of Long-Term Donor Outcomes.. Transplantation. Dec 2014. doi: 10.1097/TP.0000000000000360. [Pubmed: 25136843]
Emotional well-being of living kidney donors: findings from the RELIVE Study.. Am J Transplant. Nov 2014. doi: 10.1111/ajt.12906. Epub 2014 Oct 7. [Pubmed: 25293374]
Emotional and Financial Experiences of Kidney Donors over the Past 50 Years: The RELIVE Study.. Clin J Am Soc Nephrol. Dec 2015. doi: 10.2215/CJN.07120714. Epub 2015 Oct 13. [Pubmed: 26463883]
Resources:
Clinicaltrials.gov http://www.clinicaltrials.gov/ct2/show/NCT01158742]
NIH RePORTER http://projectreporter.nih.gov/project_info_details.cfm?aid=7099092&icde=26162432]
Assays:None
Clinical Assessments:None
SDY292: RELIVE Informed Consent Study (RELIVE-03)
Status: Updated
Description: The goal of this study was to study informed consent by the living donor. This study used surveys to evaluate the understanding of risk and psychological pressure that living organ donors felt when making the decision to donate. It compared participants' answers across geographic, racial and socio-economic backgrounds.
Program/Contract:
ProgramContract
RELIVE CLINICAL OUTCOMES OF LIVE ORGAN DONORS - DATA COORDINATING CENTER
DOI: 10.21430/M3G310ZBSI
Subjects: 636
Study PI, contact:
NameOrganizationSite
Maryam Valapour Cleveland Clinic University of Minnesota
Publications:
Assessing elements of informed consent among living donors.. Clin Transplant. Mar 2011. doi: 10.1111/j.1399-0012.2010.01374.x. [Pubmed: 21158924]
Resources:
Clinicaltrials.gov http://www.clinicaltrials.gov/ct2/show/NCT01742234]
Assays:None
Clinical Assessments:None
SDY293: Live Lung Donor Retrospective Study (RELIVE-02)
Status: Updated
Description: The purpose of this study is to determine the mortality, the early postoperative morbidity, and the occurrence of end stage lung disease for participants who underwent donor lobectomy between 1993 and 2006. Participants in this study have had donor lobectomy at the University of Southern California in Los Angeles or the Washington University Medical Center and Barnes-Jewish Hospital in St. Louis.
Program/Contract:
ProgramContract
RELIVE CLINICAL OUTCOMES OF LIVE ORGAN DONORS - DATA COORDINATING CENTER
DOI: 10.21430/M3495BHP30
Subjects: 369
Study PI, contact:
NameOrganizationSite
Akinlolu Ojo University of Michigan University of Michigan
Publications:
Morbidity and mortality of live lung donation: results from the RELIVE study.. Am J Transplant. Aug 2014. doi: - [Pubmed: 25039865]
Resources:
Clinicaltrials.gov http://www.clinicaltrials.gov/ct2/show/NCT00553397]
NIH RePORTER http://projectreporter.nih.gov/project_info_details.cfm?aid=7099088&icde=26162525]
Assays:None
Clinical Assessments:None
SDY294: Live Lung Donor Cross-sectional Cohort Study (RELIVE-05)
Status: Updated
Description: The Live Lung Donor Cross-sectional Cohort Study (RELIVE-05) aimed to determine the effects of live lung donation on lung function, quality of life, morbidity, psychosocial status, satisfaction with live lung donation, and decision-making associated with live lung donation. This study built on the separate but related RELIVE-02 retrospective study that assessed the effects of live lung donation on survival and short-term morbidity. This multicenter cross-sectional cohort study invited the RELIVE-02 living former live lung donors to undergo questionnaire and pulmonary function test assessments to further determine the long-term outcomes of live lung donation. This study used preoperative donor pulmonary function data and normative data to assist with assessing the effects of live lung donation on lung donors.
Program/Contract:
ProgramContract
RELIVE CLINICAL OUTCOMES OF LIVE ORGAN DONORS - DATA COORDINATING CENTER
DOI: 10.21430/M38LFF1QAA
Subjects: 162
Study PI, contact:
NameOrganizationSite
Mark Barr University of Southern California University of Southern California
Publications:
Morbidity and mortality of live lung donation: results from the RELIVE study.. Am J Transplant. Aug 2014. doi: - [Pubmed: 25039865]
Resources:
Clinicaltrials.gov http://www.clinicaltrials.gov/ct2/show/NCT01524835]
NIH RePORTER http://projectreporter.nih.gov/project_info_details.cfm?aid=7259520&icde=26163672]
Assays:None
Clinical Assessments:None
SDY546: FACTOR ITN507ST: Study of Tolerant Kidney Transplant Recipients
Status: Updated
Description: Following kidney (renal) transplantation, one possible complication is rejection of the new kidney. This occurs as a results of the bodys immune system attacking (or rejecting) the newly transplanted kidney. After transplant, medicines known as immunosuppressive or anti-rejection drugs are given to transplant recipients to help prevent rejection of the transplanted kidney. If a transplant recipient stops taking these medicines, they almost always reject their transplanted kidney. However, in some exceptionally rare instances, transplant recipients who stop taking these drugs do not reject their kidney, and the kidney keeps working. The recipients are said at that point to tolerate the transplanted kidney, and this condition is referred to as tolerance. In this study, participants will be asked to provide consent for the collection of extensive demographic and clinical information; medical histories; and blood and urine samples. Blood and urine samples collected will be used to perform specific assays to help define mechanisms of tolerance. Originally the study included 11 groups as listed; however, at present only groups 1,4, and 8 remain active. Whereas the initial study duration was 6 years, this was extended to 11 years in order to follow over more extended time a B cell signature identified for tolerant kidney subjects and how this signature may change. (Refer to publications section: Newell, Kirk et al, J Clin Invest. 2010).
Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Immune Tolerance Network
DOI: 10.21430/M3SBI9FQPC
Subjects: 96
Study PI, contact:
NameOrganizationSite
Kenneth Newell Emory University Immune Tolerance Network
Publications:
Identification of a B cell signature associated with renal transplant tolerance in humans.. J Clin Invest. Jun 2010. doi: 10.1172/JCI39933. Epub 2010 May 24. [Pubmed: 20501946]
Donor-specific indirect pathway analysis reveals a B-cell-independent signature which reflects outcomes in kidney transplant recipients.. Am J Transplant. Mar 2012. doi: 10.1111/j.1600-6143.2011.03869.x. Epub 2011 Dec 7. [Pubmed: 22151236]
Longitudinal studies of a B cell-derived signature of tolerance in renal transplant recipients.. Am J Transplant. Nov 2015. doi: 10.1111/ajt.13480. Epub 2015 Oct 13. [Pubmed: 26461968]
Resources:
ClinicalTrials.gov https://www.clinicaltrials.gov/ct2/show/study/NCT01338779]
ITNTrialShare.org https://www.itntrialshare.org/project/Studies/ITN507STPUBLIC/Study%20Data/begin.view]
Gene Expression Omnibus http://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE22229]
Assays:
Assay TypeNumber of Exp. Samples
DNA microarray 46
Clinical Assessments:None
SDY660: LEAP ITN032AD: Induction of Tolerance through Early Introduction of Peanut in High-Risk Children, LEAP-On ITN049AD: The Persistence of Oral Tolerance Induction to Peanut and Its Immunological Basis
Status: Updated
Description: ITN032AD: Allergic reactions to peanuts are potentially life-threatening and, in some children, can result from ingestion of only trace quantities of peanuts. At highest risk are children with eczema or who are allergic to eggs; these children have a 20% chance of developing peanut allergy by the age of five. The majority of children allergic to peanuts have their first reaction between the ages of 14 and 24 months, often at the time of their first exposure to peanut. Currently, there is no cure for peanut allergy.Peanut allergy has become an increasingly common problem in early childhood in the United States and the United Kingdom. Despite current public health guidelines in both countries recommending the avoidance of peanut consumption in the first years of life, the proportion of children with peanut allergy doubled in these countries over the period from 1998 to 2003. In contrast, peanuts are commonly consumed by infants in relatively high amounts in Africa, Southeast Asia and Israel, yet the rate of peanut allergy is quite low and does not appear to be increasing. Peanut consumption by infants in these parts of the world may actually protect children from developing peanut allergy by promoting oral tolerance to peanuts.Participants in this study will be randomly assigned to either follow a peanut consumption regimen or a strict peanut avoidance regimen. Those assigned to the peanut consumption group will be asked to consume an age-appropriate snack three times a week for the duration of the study and will be monitored closely during their first introduction to peanut.Those assigned to the peanut avoidance group will be asked to avoid ingestion of peanut for the first three years of life. A physical exam, allergy testing, and other immune system tests requiring blood collection will occur at Years 1, 3, and 5 following study entry. During the study, parents will maintain regular contact with study dietitians. ITN049AD: This is a two-sample comparison employing all available study participants in both arms of the current LEAP study at V72. After obtaining informed consent LEAP participants who are evaluable for peanut allergy at age 60 months (V60) will be enrolled into the LEAP-On Study. All LEAP-On participants will avoid peanut for an additional 12 months regardless of their previous allocation to the LEAP Study consumption arm (Group A) or the LEAP Study avoidance arm (Group B). At V72, after 12 months of this new intervention, all participants will have skinprick testing, specific IgE and a repeat oral challenge to peanut to determine the frequency of peanut allergy in both groups. The LEAP Study decision table will be used to determine the presence of peanut allergy. Briefly, peanut allergy will be based on the presence of a positive oral peanut challenge with objective signs of allergy. Tolerance will be established on the basis of a negative oral peanut challenge (tolerating 5 g of peanut protein in the absence of symptoms).
Program/Contract:
ProgramContract
ITN: Collaborative Network for Clinical Research on Immune Tolerance Network Immune Tolerance Network
DOI: 10.21430/M3SFPACKA3
Subjects: 640
Study PI, contact:
NameOrganizationSite
Gideon Lack King's College London Immune Tolerance Network
Publications:
Identifying infants at high risk of peanut allergy: the Learning Early About Peanut Allergy (LEAP) screening study.. J Allergy Clin Immunol. Jan 2013. doi: 10.1016/j.jaci.2012.09.015. Epub 2012 Nov 19. [Pubmed: 23174658]
Randomized trial of peanut consumption in infants at risk for peanut allergy.. N Engl J Med. Feb 2015. doi: 10.1056/NEJMoa1414850. Epub 2015 Feb 23. [Pubmed: 25705822]
Effect of Avoidance on Peanut Allergy after Early Peanut Consumption.. N Engl J Med. Apr 2016. doi: 10.1056/NEJMoa1514209. Epub 2016 Mar 4. [Pubmed: 26942922]
Impact of peanut consumption in the LEAP Study: Feasibility, growth, and nutrition.. J Allergy Clin Immunol. Oct 2016. doi: 10.1016/j.jaci.2016.04.016. Epub 2016 Jun 10. [Pubmed: 27297994]
Resources:
LEAP Study Information Website http://www.leapstudy.co.uk/]
Immune Tolerance Network Trialshare https://www.itntrialshare.org]
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT00329784]
ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01366846]
Assays:None
Clinical Assessments:
Allergy Skin Prick Test
Dust
Peanut Challenge Outcome at end of LEAP
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