- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03025074
Blood Collection Biorepository for Liver Disease Research
August 20, 2025 updated by: Andrew Talal, State University of New York at Buffalo
Virology, Immunology and Mechanisms of Liver Disease in Patients With Hepatitis C and Other Liver Diseases
The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.
Study Overview
Status
Recruiting
Detailed Description
The Biorepository at the University at Buffalo has been established to collect biological samples from patients with various types of liver disease.
The objectives of this biorepository are to stimulate collaboration between clinicians and researchers, to bolster training of junior investigators and to promote multidisciplinary integration to advance translational medicine and to improve the health of patients all over the country.
The purpose of this biorepository is to support investigators and to provide them with high quality specimens to promote their efforts in new discoveries or perfecting treatment of patients with liver diseases caused by Non-Alcoholic Fatty Liver Disease (NAFLD), Non-Alcoholic Steatohepatitis (NASH), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and Human Immunodeficiency Virus (HIV).
The goal is to obtain samples that represent patients seen in the clinics of medical centers in Western NY and from some of the rarer diseases encountered in these clinics.
The ultimate goal is to develop the biorepository as Western New York's resource for clinically annotated human samples that can be used to conduct research that could lead to significant advances in patient care.
Study Type
Observational
Enrollment (Estimated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Barbara Bauer, BA
- Phone Number: 716-888-4825
- Email: bmbauer@buffalo.edu
Study Locations
-
-
New York
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Buffalo, New York, United States, 14203
- Recruiting
- University at Buffalo, Buffalo General Medical Center
-
Contact:
- Barbara Bauer, BA
- Phone Number: 716-888-4825
- Email: bmbauer@buffalo.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Subjects with NASH, NAFLD, Fibrosis, Cirrhosis, Hepatitis B or C, HIV or any form of Liver Disease.
Description
Inclusion Criteria:
- This protocol is to establish a biobank of blood samples from individuals with or without liver diseases including viral hepatitis, liver cancer, NASH, and negative control samples.
- Children and teenagers will be special populations considered in this protocol.
Exclusion Criteria:
- Vulnerable populations such as adults unable to consent, infants, pregnant women or prisoners will not be considered for this research study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of samples collected
Time Frame: 52 weeks
|
Total number of samples collected
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrew Talal, MD, University at Buffalo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Zeremski M, Sylvester C, Talal AH. Response to Commentary on Zeremski et al. (2016): Improvements in HCV-related Knowledge Among Substance Users on Opioid Agonist Therapy After an Educational Intervention. J Addict Med. 2016 Sep-Oct;10(5):364-5. doi: 10.1097/ADM.0000000000000240. No abstract available.
- Juluru K, Talal AH, Yantiss RK, Spincemaille P, Weidman EK, Giambrone AE, Jalili S, Sourbron SP, Dyke JP. Diagnostic accuracy of intracellular uptake rates calculated using dynamic Gd-EOB-DTPA-enhanced MRI for hepatic fibrosis stage. J Magn Reson Imaging. 2017 Apr;45(4):1177-1185. doi: 10.1002/jmri.25431. Epub 2016 Aug 16.
- Zeremski M, Dimova RB, Pillardy J, de Jong YP, Jacobson IM, Talal AH. Fibrosis Progression in Patients With Chronic Hepatitis C Virus Infection. J Infect Dis. 2016 Oct 15;214(8):1164-70. doi: 10.1093/infdis/jiw332. Epub 2016 Aug 2.
- Ocque AJ, Hagler CE, Difrancesco R, Woolwine-Cunningham Y, Bednasz CJ, Morse GD, Talal AH. Development and validation of a UPLC-MS/MS method for the simultaneous determination of paritaprevir and ritonavir in rat liver. Bioanalysis. 2016 Jul;8(13):1353-63. doi: 10.4155/bio-2016-0040. Epub 2016 Jun 9.
- Zeremski M, Zavala R, Dimova RB, Chen Y, Kritz S, Sylvester C, Brown LS Jr, Talal AH. Improvements in HCV-related Knowledge Among Substance Users on Opioid Agonist Therapy After an Educational Intervention. J Addict Med. 2016 Mar-Apr;10(2):104-9. doi: 10.1097/ADM.0000000000000196.
- Bednasz CJ, Sawyer JR, Martinez A, Rose PG, Sithole SS, Hamilton HR, Kaufman FS, Venuto CS, Ma Q, Talal A, Morse GD. Recent advances in management of the HIV/HCV coinfected patient. Future Virol. 2015;10(8):981-997. doi: 10.2217/fvl.15.64.
- Cloherty G, Talal A, Coller K, Steinhart C, Hackett J Jr, Dawson G, Rockstroh J, Feld J. Role of Serologic and Molecular Diagnostic Assays in Identification and Management of Hepatitis C Virus Infection. J Clin Microbiol. 2016 Feb;54(2):265-73. doi: 10.1128/JCM.02407-15. Epub 2015 Dec 9.
- Zeremski M, Dimova RB, Benjamin S, Penney MS, Botfield MC, Talal AH. Intrahepatic and Peripheral CXCL10 Expression in Hepatitis C Virus-Infected Patients Treated With Telaprevir, Pegylated Interferon, and Ribavirin. J Infect Dis. 2015 Jun 1;211(11):1795-9. doi: 10.1093/infdis/jiu807. Epub 2014 Dec 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Estimated)
December 1, 2099
Study Completion (Estimated)
December 1, 2099
Study Registration Dates
First Submitted
January 16, 2017
First Submitted That Met QC Criteria
January 18, 2017
First Posted (Estimated)
January 19, 2017
Study Record Updates
Last Update Posted (Estimated)
August 27, 2025
Last Update Submitted That Met QC Criteria
August 20, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Pathologic Processes
- Nutrition Disorders
- Overnutrition
- Body Weight
- Infections
- RNA Virus Infections
- Virus Diseases
- Digestive System Diseases
- Hepatitis, Viral, Human
- Communicable Diseases
- DNA Virus Infections
- Flaviviridae Infections
- Overweight
- Hepadnaviridae Infections
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Obesity
- Hepatitis
- Fibrosis
- Liver Diseases
- Fatty Liver
- Non-alcoholic Fatty Liver Disease
- Hepatitis B
- Pediatric Obesity
- Hepatitis C
Other Study ID Numbers
- Biobank Blood
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The Biorepository was created to provide high quality specimens to future researchers to advance their clinical and translational research.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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