Immune Monitoring and Assay Development in Organ Transplant Recipients

NCT ID: NCT01283295

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2025-12-31

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Stable Transplant Recipient

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

No interventions assigned to this group

Pre-Transplant Longitudinal

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

No interventions assigned to this group

Organ Donors

Donors for individuals meeting the criteria for Cohorts 1-3

No interventions assigned to this group

Disease state

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

No interventions assigned to this group

Normal Volunteers

No interventions assigned to this group

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Aneesh K. Mehta

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aneesh K Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status: RECRUITING

Emory University

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shine Thomas, CRC

Role: CONTACT

shine.thomas@emoryhealthcare.org

404-712-2004

Facility Contacts

Tauri Harden, CRC

Role: primary

Other Identifiers

IRB00006248

Identifier Type: -

Identifier Source: org_study_id