Discovery and Validation of Proteogenomic Biomarker Panels in Liver Transplant Recipients (PROGENI-LI)

September 1, 2016 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood and Urine Monitoring Study of Liver Transplant Recipients - Transplant Proteogenomics

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University, Feinberg School of Medicine
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44295
        • Cleveland Clinic Foundation
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Liver Transplant Recipients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Liver Transplant Recipients

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months after liver transplant
Acute Rejection
Time Frame: 12 months after liver transplant
12 months after liver transplant
Acute Rejection
Time Frame: 24 months after liver transplant
24 months after liver transplant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline (Visit 1) to Month 24 (Visit 12):
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
Baseline (Visit 1) to Month 24 (Visit 12)
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
Baseline (Visit 1) to Month 24 (Visit 12)
Incidence of death, graft loss, and need for liver retransplantation
Time Frame: Baseline (Visit 1) to Month 24 (Visit 12)
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)
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)
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)
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)
Baseline (Visit 1) to Month 24 (Visit 12)
Protein expression profiles of urine (CKD)
Time Frame: Baseline (Visit 1) to Month 24 (visit 12)
Baseline (Visit 1) to Month 24 (visit 12)
microRNA Profiling Plasma & Cells
Time Frame: Baseline (Visit 1) to Month 24 (Visit 12)
Baseline (Visit 1) to Month 24 (Visit 12)
Multiparameter Flow Cytometry - Viral Pathogens
Time Frame: Baseline (Visit 1) to Month 24 (Visit 12)
Baseline (Visit 1) to Month 24 (Visit 12)
Viral Monitoring - EBV & CMV
Time Frame: Baseline (Visit 1) to Month 24 (Visit 12)
Baseline (Visit 1) to Month 24 (Visit 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Clinical Trials in Organ Transplantation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Josh Levitsky, MD, MS, Northwestern University Feinberg School Of Medicine
  • Principal Investigator: Michael Abecassis, MD, MBA, Northwestern University Feinberg School Of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DAIT CTOT-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings