Immune Monitoring and Assay Development in Organ Transplant Recipients (IMP)
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Purpose
The purpose of this study to develop a well-characterized library of blood, biopsy tissue, and urine samples from transplant patients. Subjects without transplants will also be enrolled for comparison. Samples will be used to study the characteristics of patients undergoing transplantation that influence their response to transplant therapies and their reactions to drugs used in transplantation. This knowledge is important as it helps physicians design new drugs and tailor transplant therapies to the individual thereby reducing the side effects. In this study, people will be asked to donate blood, biopsy tissue and urine. Donation of these samples will not influence patients' treatments. These samples will be tested using a variety of biological tests to better understand how immunosuppressive drugs change the various components of the immune system. The tests will be for research only; no changes in an individual's treatment will be based on the results of tests performed in this study. If there is extra sample, the sample will be stored for use in other testing at a later date. The ultimate goal is find the right combination of medications for each individual patient while keeping their new organ working well. This study is a first step in that direction by perfecting tests used to characterize a patient's immune system
| Condition |
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Organ Transplant Immunology |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Immune Monitoring and Assay Development in Organ Transplant Recipients |
PBMCs, serum, urine, kidney and liver biopsy samples, broncheolar lavage fluid
| Estimated Enrollment: | 5000 |
| Study Start Date: | November 2007 |
| Groups/Cohorts |
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Immune complications
Transplant recipients who develop a clinically recognized complication with potential immune etiology or ramifications. Examples include opportunistic infection, rejection, malignancy, alloantibody formation or immunosuppressive drug toxicity.
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Stable Transplant Recipient
Patients who demonstrate immune stability characterized by stable graft function without evident complication. These patients serve as comparators for Group 1
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Pre-Transplant Longitudinal
Patients who are candidates for kidney, pancreas, liver or lung transplant will be enrolled and followed longitudinally.
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Organ Donors
Donors for individuals meeting the criteria for Cohorts 1-3
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Disease state
Individuals with liver, renal or pulmonary diseases that may lead to the development or organ failure.
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| Normal Volunteers |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
pediatric or adult organ transplant recipients, candidates for organ transplant, donors and normal volunteers of Emory University Hospital, the Emory Transplant Center or Children's Healthcare of Atlanta (CHOA)
Inclusion Criteria:
- recipients of or candidates for organ transplantation or organ donors for recipients under evaluation at Emory University or CHOA
- normal volunteers, including individuals without any known end-stage organ disease who are not on any immunosuppressive medication, and individuals with conditions requiring immunosuppression (i.e. dermatological diseases) that do not require transplant therapies
- ability to understand the purposes and risks of the study and willingly give written informed consent, or in the case of minors, ability to give minor assent (children older than 5 years of age), in conjunction with written guardian consent
Exclusion Criteria:
- patients who fail to meet the criteria for transplantation or post-transplant follow-up by Emory or Childrens Healthcare of Atlanta physicians
- Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating. Specific conditions include but are not limited to: anemia prohibitive of phlebotomy, coagulopathy or technical considerations that would prevent acquisition of sufficient tissue on biopsy for clinical use, or medical urgency preventing timely administration of the consenting process.
Contacts and Locations| Contact: Shine Thomas, CRC | 404-712-2004 | shine.thomas@emoryhealthcare.org |
| Contact: Beth Begley, RN | 404-712-7168 | beth.begley@emoryhealthcare.org |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Children's Healthcare of Atlanta | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Tauri Harden, CRC | |
| Principal Investigator: | Allan D. Kirk, MD, PhD | Emory University |
More Information
No publications provided
| Responsible Party: | Allan D Kirk, MD, PhD, Professor of Surgery and Pediatrics, Emory University |
| ClinicalTrials.gov Identifier: | NCT01283295 History of Changes |
| Other Study ID Numbers: | IMP |
| Study First Received: | January 24, 2011 |
| Last Updated: | November 5, 2012 |
| Health Authority: | United States: Emory University Institutional Review Board |
ClinicalTrials.gov processed this record on May 23, 2013