Discovery and Validation of Proteogenomic Biomarker Panels in Liver Transplant Recipients (CTOT-14)
This study is not yet open for participant recruitment.
Verified August 2012 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01672164
First received: August 16, 2012
Last updated: August 21, 2012
Last verified: August 2012
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Purpose
The main focus of this study is to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had a liver transplant. Researchers will examine blood, urine, and tissue samples and try to identify markers for certain conditions such as rejection, response to therapy, and scarring of the liver. Additionally, researchers would like to identify biomarkers that can detect damage to the native kidneys before blood levels of creatinine rises. By studying gene expression, researchers hope to be able to diagnose these conditions earlier and improve liver survival.
| Condition |
|---|
|
Proteogenomic Monitoring in Liver Transplant Recipients |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood & Urine Monitoring Study of Liver Transplant Recipients |
Resource links provided by NLM:
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Primary Outcome Measures:
- Acute Rejection [ Time Frame: 3 months after liver transplant ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
- Acute Rejection [ Time Frame: 24 months after liver transplant ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Severity of acute rejection [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12): ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]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) ] [ Designated as safety issue: Yes ]
- Incidence of opportunistic infections, malignancy, and cardiovascular complications [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ] [ Designated as safety issue: Yes ]
- mRNA expression profiles of peripheral blood (AR, HCV-R, CKD) [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ] [ Designated as safety issue: No ]
- mRNA expression profiles of liver biopsies (AR, HCV-R) [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ] [ Designated as safety issue: No ]
- Protein expression profiles of plasma ( AR, HCV-R, CKD) [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ] [ Designated as safety issue: No ]
- Protein expression profiles of urine (CKD) [ Time Frame: Baseline (Visit 1) to Month 24 (visit 12) ] [ Designated as safety issue: No ]
- microRNA Profiling Plasma & Cells [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ] [ Designated as safety issue: No ]
- Multiparameter Flow Cytometry - Viral Pathogens [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ] [ Designated as safety issue: No ]
- Viral Monitoring - EBV & CMV [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
whole blood, plasma, serum, urine supernatant, urine pellet and tissue
| Estimated Enrollment: | 300 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2015 |
| Groups/Cohorts |
|---|
| Liver Transplant Recipients |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Liver Transplant Recipients
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672164
Contacts
| Contact: Merideth Brown, MS | brownmeri@niaid.nih.gov |
Locations
| United States, Arizona | |
| Mayo Clinic | Not yet recruiting |
| Phoenix, Arizona, United States, 85054 | |
| Contact: Michael Leonard leonard.michael@mayo.edu | |
| Contact: Adyr Moss, MD moss.adyr@mayo.edu | |
| Principal Investigator: Adyr Moss, MD | |
| United States, California | |
| Scripps Center for Organ and Cell Transplantation | Not yet recruiting |
| La Jolla, California, United States, 92037 | |
| Contact: Shannon Cyhan cyhan.shannon@scrippshealth.org | |
| Principal Investigator: Christopher Marsh, MD | |
| United States, Illinois | |
| Northwestern University, Feinberg School of Medicine | Not yet recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: jane charette, RN, BSN, CCRC jane-charette@northwestern.edu | |
| Principal Investigator: Josh Levitsky, MD, MS | |
| United States, Ohio | |
| Cleveland Clinic Foundation | Not yet recruiting |
| Cleveland, Ohio, United States, 44295 | |
| Contact: Sue Thomas Thomass4@ccf.org | |
| Principal Investigator: Charles Miller, MD | |
| United States, South Carolina | |
| Medical University of South Carolina | Not yet recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Erin Hart harer@musc.edu | |
| Principal Investigator: PRABHAKAR BALIGA, MD | |
| United States, Texas | |
| Baylor University Medical Center | Not yet recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Goran KLINTMALM, MD,Ph.D, FACS 214-820-1757 gorank@baylorhealth.edu | |
| Principal Investigator: Goran Klintmalm, MD, PhD, FACS | |
Sponsors and Collaborators
Investigators
| Study Chair: | Josh Levitsky, MD, MS | Northwestern Univ. |
| Principal Investigator: | MICHAEL ABECASSIS, MD, MBA | Northwestern Univ. |
More Information
No publications provided
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT01672164 History of Changes |
| Other Study ID Numbers: | DAIT CTOT-14 |
| Study First Received: | August 16, 2012 |
| Last Updated: | August 21, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
liver transplantation |
ClinicalTrials.gov processed this record on May 23, 2013