Gene Expression in Liver Allograft Rejection and Recurrent Hepatitis C
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|ClinicalTrials.gov Identifier: NCT01428700|
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : March 22, 2023
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|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||275 participants|
|Official Title:||Development of Gene Expression Signatures for the Diagnosis of Liver Allograft Rejection and Recurrent Hepatitis C Disease (CTOT-07)|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
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
- 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 ]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
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428700
|Principal Investigator:||Abraham Shaked, MD, PhD||University of Pennsylvania|
|Study Chair:||Manikkam Suthanthiran, MD||Cornell University|
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|Other Study ID Numbers:||
|First Posted:||September 5, 2011 Key Record Dates|
|Last Update Posted:||March 22, 2023|
|Last Verified:||March 2023|
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections