Immune Monitoring and Assay Development in Organ Transplant Recipients
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/24/2018 |
| Start Date: | November 2007 |
| End Date: | December 2025 |
| Contact: | Shine Thomas, CRC |
| Email: | shine.thomas@emoryhealthcare.org |
| Phone: | 404-712-2004 |
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
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
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.
We found this trial at
2
sites
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
Click here to add this to my saved trials
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
Click here to add this to my saved trials