Discovery and Validation of Proteogenomic Biomarker Panels in Liver Transplant Recipients (CTOT-14)

This study is ongoing, but not recruiting participants.
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: February 4, 2015
Last verified: February 2015
  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


Enrollment: 202
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672164

Locations
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
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
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: February 4, 2015
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 July 01, 2015