Gene Expression in Liver Allograft Rejection and Recurrent Hepatitis C

NCT01428700 | Completed

• 1 other identifier: DAIT CTOT-07
• Study Type: observational
• Target: 275
• Locations: 0 countries
• Sites: N/A

Brief Summary

Acute cellular rejection is relatively common after liver transplantation, typically does not affect graft survival, and is not associated with the development of chronic rejection. Acute cellular rejection is diagnosed when liver enzymes and/or liver function tests are elevated when compared to baseline. The only means of differentiating acute rejection from other liver pathologies is with a liver biopsy. However, even with this invasive diagnostic procedure, it may be difficult to distinguish acute rejection from another disease process, such as injury caused by the hepatitis C virus (HCV) from the native liver. This study will evaluate whether certain patterns of biomarkers in the peripheral blood and/or liver tissue of a liver transplant recipient can be used to determine if the transplanted liver is being rejected by the recipient or sustaining HCV injury. Diagnostic biomarkers that are specific for acute rejection and informative of the severity of HCV recurrence could allow for modulation of immunosuppression therapy and treat the clinical condition without the need for invasive liver biopsies.

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• Expression levels of mRNA and miRNA in peripheral blood cells, serum, and tissue at the time of for cause and protocol biopsies, and the diagnostic effectiveness of identified patterns

  This assay study will analyze expression levels of mRNA and miRNA from NINV and HCV liver biopsy, whole blood, and/or serum samples from the ITN030ST study obtained within a +/- 10-day window of the biopsy.

  +/- 10 day window from time of clinically indicated biopsy

Study Arms (2)

Non-Immune/Non-Viral (NINV)

Patients enrolled in ITN030ST transplanted for liver failure resulting from non-viral, non-immune causes

Hepatitis C Virus (HCV) positive

Patients enrolled in ITN030ST transplanted for liver failure resulting from HCV genotype 1 infection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled in ITN030ST (NCT00135694)

You may qualify if:

• Specimens derived from subjects enrolled in the ITN030ST study.
• Availability of adequate biopsy specimens with corresponding blood and/or serum collected within a 10 day window of a for-cause or protocol biopsy.

You may not qualify if:

• Withdrawal of consent for the ITN030ST study.
• Absence of consent in the ITN030ST study for the collection and storage of samples of blood and tissue for future research studies.

Sponsors & Collaborators

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

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

Liver tissue, whole blood, and serum specimens

Study Officials

• Abraham Shaked, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Manikkam Suthanthiran, MD

  Cornell University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: September 5, 2011
• Study Start: August 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 22, 2023

Record last verified: 2023-03