Discovery and Validation of Proteogenomic Biomarker Panels in Liver Transplant Recipients (PROGENI-LI)
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ClinicalTrials.gov Identifier: NCT01672164 |
Recruitment Status :
Completed
First Posted : August 24, 2012
Last Update Posted : September 2, 2016
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Condition or disease |
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Liver Transplant Recipients Liver Transplantation |
Study Type : | Observational |
Actual Enrollment : | 202 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood and Urine Monitoring Study of Liver Transplant Recipients - Transplant Proteogenomics |
Study Start Date : | August 2012 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | December 2015 |

Group/Cohort |
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Liver Transplant Recipients |
- Acute Rejection [ Time Frame: 3 months after liver transplant ]The primary endpoint is the incidence of biopsy proven AR at 3, 12 and 24 months after LT.
- Acute Rejection [ Time Frame: 12 months after liver transplant ]
- Acute Rejection [ Time Frame: 24 months after liver transplant ]
- Severity of acute rejection [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12): ]Severity (initial grade, steroid-responsive vs. refractory by biopsy) and clinical/biochemical resolution following treatment of AR
- Recurrent Hepatitis-C Virus (HCV-R) [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]Incidence, severity (grade, stage), and treatment (requirement for, response rates) of HCV-R
- Chronic Kidney Disease(CKD) [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]Incidence, severity (stage, need for renal replacement therapy or kidney transplantation), and response to treatment (CNI reduction/withdrawal ± MPA or mTOR) of CKD
- Incidence of death, graft loss, and need for liver retransplantation [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]
- Incidence of opportunistic infections, malignancy, and cardiovascular complications [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]
- mRNA expression profiles of peripheral blood (AR, HCV-R, CKD) [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]
- mRNA expression profiles of liver biopsies (AR, HCV-R) [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]
- Protein expression profiles of plasma ( AR, HCV-R, CKD) [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]
- Protein expression profiles of urine (CKD) [ Time Frame: Baseline (Visit 1) to Month 24 (visit 12) ]
- microRNA Profiling Plasma & Cells [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]
- Multiparameter Flow Cytometry - Viral Pathogens [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]
- Viral Monitoring - EBV & CMV [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Subjects undergoing primary deceased-donor or living donor liver transplantation;
- Subject must be able to understand and provide informed consent.
Exclusion Criteria:
- Need for combined organ transplantation;
- Previous solid organ and/or islet cell transplantation;
- Infection with HIV;
- Allergy to iodine;
- Inability or unwillingness of a participant to comply with study protocol;
- Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672164
United States, Arizona | |
Mayo Clinic | |
Phoenix, Arizona, United States, 85054 | |
United States, Illinois | |
Northwestern University, Feinberg School of Medicine | |
Chicago, Illinois, United States, 60611 | |
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44295 | |
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 | |
United States, Texas | |
Baylor University Medical Center | |
Dallas, Texas, United States, 75246 |
Study Chair: | Josh Levitsky, MD, MS | Northwestern University Feinberg School of Medicine | |
Principal Investigator: | Michael Abecassis, MD, MBA | Northwestern University Feinberg School of Medicine |
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT01672164 |
Other Study ID Numbers: |
DAIT CTOT-14 |
First Posted: | August 24, 2012 Key Record Dates |
Last Update Posted: | September 2, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The plan is to share data in ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools that are available to researchers who register online and subsequently receive DAIT approval. |
proteogenomic biomarker panels |