Gene Expression in Liver Allograft Rejection and Recurrent Hepatitis C
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Purpose
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.
| Condition |
|---|
|
Liver Transplantation |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | Development of Gene Expression Signatures for the Diagnosis of Liver Allograft Rejection and Recurrent Hepatitis C Disease (CTOT-07) |
- 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 [ Time Frame: +/- 10 day window from time of clinically indicated biopsy ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Liver tissue, whole blood, and serum specimens
| Study Start Date: | August 2011 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients enrolled in ITN030ST (NCT00135694)
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT01428700 History of Changes |
| Other Study ID Numbers: | DAIT CTOT-07 |
| Study First Received: | September 1, 2011 |
| Last Updated: | February 13, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on May 23, 2013