Clinical trial NCT01283295: Immune Monitoring and Assay Development in Organ Transplant Recipients
Official title: Immune Monitoring and Assay Development in Organ Transplant Recipients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Organ Transplantation
Transplantation Immunology
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2011-01-25
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Recipients of or candidates for organ transplantation or organ donors for recipients under evaluation at Emory University or CHOA
* Normal volunteers to include 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 Children's 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.

Primary outcomes:
measure: To generate a bank of well-characterized biological samples from human subjects prior to or following organ transplantation for the purpose of subsequent evaluation using new and existing immunological assays
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Aneesh K Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References: