Discovery and Validation of Proteogenomic Biomarker Panels in Liver Transplant Recipients

NCT01672164 | Completed DMC

• 1 other identifier: DAIT CTOT-14
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 6

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.

Conditions

Liver Transplant Recipients; Liver Transplantation

Keywords

proteogenomic biomarker panels

Outcome Measures

Primary Outcomes (3)

• Acute Rejection

  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

  12 months after liver transplant

• Acute Rejection

  24 months after liver transplant

Secondary Outcomes (12)

• Severity of acute rejection

  Baseline (Visit 1) to Month 24 (Visit 12):

• Recurrent Hepatitis-C Virus (HCV-R)

  Baseline (Visit 1) to Month 24 (Visit 12)

• Chronic Kidney Disease(CKD)

  Baseline (Visit 1) to Month 24 (Visit 12)

• Incidence of death, graft loss, and need for liver retransplantation

  Baseline (Visit 1) to Month 24 (Visit 12)

• Incidence of opportunistic infections, malignancy, and cardiovascular complications

  Baseline (Visit 1) to Month 24 (Visit 12)

Study Arms (1)

Liver Transplant Recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Liver Transplant Recipients

You may qualify if:

• Subjects undergoing primary deceased-donor or living donor liver transplantation;
• Subject must be able to understand and provide informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Clinical Trials in Organ Transplantation: collaborator

Study Sites (6)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44295, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)
• Clinical Trials in Organ Transplantation (CTOT)

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, plasma, serum, urine supernatant, urine pellet and tissue

Study Officials

• Josh Levitsky, MD, MS

  Northwestern University Feinberg School of Medicine

  STUDY CHAIR

• Michael Abecassis, MD, MBA

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 24, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 2, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

US (6)