Discovery and Validation of Proteogenomic Biomarker Panels in Liver Transplant Recipients

NCT ID: NCT01672164

Last Updated: 2016-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Transplant Recipients Liver Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Liver Transplant Recipients

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Trials in Organ Transplantation

NETWORK

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josh Levitsky, MD, MS

Role: STUDY_CHAIR

Northwestern University Feinberg School of Medicine

Michael Abecassis, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

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Mayo Clinic

Phoenix, Arizona, United States

Site Status

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, United States

Site Status

Mount Sinai School of Medicine

New York, New York, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Baylor University Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.niaid.nih.gov

National Institute of Allergy and Infectious Diseases (NIAID)

http://www.ctotstudies.org/

Clinical Trials in Organ Transplantation (CTOT)

Other Identifiers

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DAIT CTOT-14

Identifier Type: -

Identifier Source: org_study_id

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