Developing a library of samples from organ transplant patients
Immune Monitoring and Assay Development in Organ Transplant Recipients
Emory University · NCT01283295
This study is collecting blood, tissue, and urine samples from organ transplant patients and healthy volunteers to see how their bodies respond to transplant treatments and medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Sex | All |
| Sponsor | Emory University (other) |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT01283295 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a well-characterized library of blood, biopsy tissue, and urine samples from organ transplant recipients, as well as from healthy volunteers for comparison. The samples will be analyzed to understand how patients respond to transplant therapies and the immunosuppressive drugs used in transplantation. By studying these biological samples, researchers hope to tailor transplant therapies to individual patients, potentially reducing side effects. Participation involves donating samples, which will not affect the participants' treatment plans.
Who should consider this trial
Good fit: Ideal candidates include organ transplant recipients, candidates for transplantation, and healthy volunteers without end-stage organ disease.
Not a fit: Patients who do not meet the criteria for transplantation or have conditions that pose undue risk may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized transplant therapies that minimize side effects for patients.
How similar studies have performed: Other studies have shown success in using biological samples to improve transplant therapies, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Atlanta, Georgia and 1 other locations
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (RECRUITING)
- Emory University — Atlanta, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Aneesh K Mehta, MD — Emory University
- Study coordinator: Shine Thomas, CRC
- Email: shine.thomas@emoryhealthcare.org
- Phone: 404-712-2004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Organ Transplantation, Transplantation Immunology