Immune Monitoring and Assay Development in Organ Transplant Recipients

NCT01283295 | Unknown

• 1 other identifier: IRB00006248
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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

  Ongoing

Study Arms (6)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

PBMCs, serum, urine, kidney and liver biopsy samples, broncheolar lavage fluid

Study Officials

• Aneesh K Mehta, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shine Thomas, CRC

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: January 25, 2011
• Study Start: November 1, 2007
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)