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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
Sponsor:
Collaborator:
Clinical Trials in Organ Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Brief Summary:
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 or disease
Liver Transplant Recipients Liver Transplantation

Study Design
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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

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Groups and Cohorts
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Group/Cohort
Liver Transplant Recipients


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Acute Rejection [ Time Frame: 12 months after liver transplant ]
  3. Acute Rejection [ Time Frame: 24 months after liver transplant ]

Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Incidence of death, graft loss, and need for liver retransplantation [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]
  5. Incidence of opportunistic infections, malignancy, and cardiovascular complications [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]
  6. mRNA expression profiles of peripheral blood (AR, HCV-R, CKD) [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]
  7. mRNA expression profiles of liver biopsies (AR, HCV-R) [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]
  8. Protein expression profiles of plasma ( AR, HCV-R, CKD) [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]
  9. Protein expression profiles of urine (CKD) [ Time Frame: Baseline (Visit 1) to Month 24 (visit 12) ]
  10. microRNA Profiling Plasma & Cells [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]
  11. Multiparameter Flow Cytometry - Viral Pathogens [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]
  12. Viral Monitoring - EBV & CMV [ Time Frame: Baseline (Visit 1) to Month 24 (Visit 12) ]

Biospecimen Retention:   Samples With DNA
whole blood, plasma, serum, urine supernatant, urine pellet and tissue

Eligibility Criteria
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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
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
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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


Locations
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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
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Clinical Trials in Organ Transplantation
Investigators
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Study Chair: Josh Levitsky, MD, MS Northwestern University Feinberg School of Medicine
Principal Investigator: Michael Abecassis, MD, MBA Northwestern University Feinberg School of Medicine
More Information
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Additional Information:

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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.
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
proteogenomic biomarker panels