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Determine the levels of Donor-derived (dd)cell-free DNA(cfDNA )in liver transplant recipients with normal liver function tests (LFTs) indicating stable immunosuppression status (IS). Based on this range use the dd-cfDNA levels to determine over or under IS in liver transplant patients to make changes to their IS medication regimen.
dd-cfDNA is a non-invasive method to measure graft function stability in liver transplant patients. Liver biopsy is the standard to determine liver rejection and graft function, but no tests exist currently to be able to help guide the IS regimen in these patients. LFTs are not as specific to determine graft function hence testing dd-cfDNA levels can help guide the Immunosuppression (IS )medications dosing and help identify rejection early.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| donor-derived cell free DNA in liver | Behavioral | Determine the difference in age, gender, LFTs, IS regimen (tacrolimus/sirolimus/cyclosporin with mycophenolate mofetil (MMF) and /or prednisone) between patients who underwent liver transplant <1 year PTX and >1 year PTX |
| Measure | Description | Time Frame |
|---|---|---|
| dd-cfDNA range in liver transplant patients | Determine the dd-cfDNA in liver transplant patients with stable IS collected from July 2021 to July 2024 and compare the range between patients with <1-year post-transplant (PTX) and >1-year PTX by chart review using Methodist hospital data system. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Demographics: age (years), gender (male/female), race (Caucasian, Black, Hispanic, Asian, Other) | Demographics differences in patients who underwent liver transplant less than 1 year of PTX and more than 1 year PTX | 1 year |
| Days post-transplant at first dd-cfDNA |
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Inclusion Criteria:
Exclusion Criteria:
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Patients included in the study should be at least 18 years of age, who have underwent a liver transplant and at least have one level of dd-cfDNA documented.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kavya Vinod Mankulangara, PharmD | Contact | 214-947-4681 | MHSIRB@mhd.com | |
| Bethany Brauer, MPH | Contact | 214-947-4681 | mhsirb@mhd.com |
| Name | Affiliation | Role |
|---|---|---|
| Parvez Mantry, MD | Methodist Midlothian Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist Dallas Medical Center | Recruiting | Dallas | Texas | 75203 | United States |
Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals
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2 years
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| ID | Term |
|---|---|
| D008110 | Liver Extracts |
| ID | Term |
|---|---|
| D014020 | Tissue Extracts |
| D045424 | Complex Mixtures |
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Number of days post transplant at first dd-cfDNA |
| 1 year |
| LFTs: Alanine transaminase(ALT), Aspartate transaminase(AST),Alkaline phosphatase( ALP), total bilirubin (Tbili) | looking at the liver function tests in patients who underwent liver transplant less than 1 year of PTX and more than 1 year PTX | 1 year |
| Serum Creatinine | Measuring the serum creatinine levels | 1 year |