Recruiting

Immune Monitoring

Sponsor:

Emory University

Code:

NCT01283295

Conditions

Organ Transplantation

Transplantation Immunology

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Study Details

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

Conditions

Organ Transplantation

Transplantation Immunology

Study ID

NCT01283295

Start date

Nov, 2007

Status verified date

Sep, 2023

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Stable Transplant Recipient

Patients who demonstrate immune stability characterized by stable graft function without evident complication. These patients serve as comparators for Group 1

Pre-Transplant Longitudinal

Patients who are candidates for kidney, pancreas, liver or lung transplant will be enrolled and followed longitudinally.

Organ Donors

Donors for individuals meeting the criteria for Cohorts 1-3

Disease state

Individuals with liver, renal or pulmonary diseases that may lead to the development or organ failure.

Normal Volunteers

Primary outcome 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 [ Time Frame: Ongoing ]

Central Contacts and Locations

Central contacts

Shine Thomas, CRC

404-712-2004shine.thomas@emoryhealthcare.org

Locations

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

More Information

Sponsor

Emory University

Last update posted

Sep 8, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2023-09-08.