Proteogenomic Monitoring and Assessment of Liver Transplant Recipients

NCT01644903 | Recruiting

• 1 other identifier: STU 26737
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to test blood, urine and tissue samples to see if this can help decide if CKD (Chronic Kidney Disease), AR (Acute Rejection) and HCV (Hepatitis C Virus) can be identified in its early stages. CKD damage to the kidneys, AR and HCV all lower the body's ability to function properly. Early detection of these conditions could assist with successful treatment and possibly lead to less repeat organ transplants.

Conditions

Liver Transplant; Hepatitis C; Chronic Kidney Disease; Acute Rejection

Outcome Measures

Primary Outcomes (1)

• Proteogenomic Biomarkers for CKD, AR and HCV

  To validate specific proteogenomic biomarker panels for CKD and AR (and HCV) in a prospective serial blood and urine monitoring study of liver transplant recipients

  At time of liver biopsy

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

The intention of our biomarker panel is to be broadly applicable to all patients with liver transplant with the assumption that there are common underlying molecular mechanisms of CKD and AR (and HCV) that can be detected hopefully at early stages of disease. We therefore want to validate and test our biomarker panel in a broad collection of patient types.

You may qualify if:

• Male and female recipients of all races, ≥18 years of age.
• Patients undergoing primary or subsequent living or deceased donor liver transplantation.
• Subject and/or guardian must be able to provide informed consent.
• Subject and/or guardian must be able to comply with the study protocol.

You may not qualify if:

• \. Inability or unwillingness of a participant and/or guardian to provide informed consent.

Sponsors & Collaborators

• Northwestern University: lead
• The Scripps Research Institute: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Urine Sample - One half cup of urine (100 mL) will be taken for research tests at each study visit. Blood Sample - About 1.5 tablespoons (20.5 mL) will be taken for research tests at each study visit. Liver Biopsy - A liver biopsy is a procedure to remove and examine a small piece of liver tissue. For this study, an extra tissue sample will possibly be taken during your biopsy. One additional needle pass may be made to collect the sample for this study.

MeSH Terms

Conditions

Hepatitis C; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Josh Levitsky, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Misael Villegas, BA

CONTACT

misael.villegas@northwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Transplant Hepatologist

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 19, 2012
• Study Start: April 1, 2010
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

US (1)