Blood Collection Biorepository for Liver Disease Research

NCT03025074 | Recruiting DMC

• 1 other identifier: Biobank Blood
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-Alcoholic Steatohepatitis(NASH); Hepatitis C; Hepatitis B; Fibrosis; Cirrhosis; Fatty Liver; Obesity, Childhood; Bariatric Surgery Candidate

Keywords

Liver Disease; Obesity; Hepatitis; HIV; Hepatology

Outcome Measures

Primary Outcomes (1)

• Number of samples collected

  Total number of samples collected

  52 weeks

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with NASH, NAFLD, Fibrosis, Cirrhosis, Hepatitis B or C, HIV or any form of Liver Disease.

You may qualify if:

• 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.

You may not qualify if:

• Vulnerable populations such as adults unable to consent, infants, pregnant women or prisoners will not be considered for this research study.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

University at Buffalo, Buffalo General Medical Center

Buffalo, New York, 14203, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 27685683 BACKGROUND

• 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.

  PMID: 27527820 BACKGROUND

• 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.

  PMID: 27485356 BACKGROUND

• 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.

  PMID: 27277877 BACKGROUND

• 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.

  PMID: 26881485 BACKGROUND

• 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.

  PMID: 26877758 BACKGROUND

• 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.

  PMID: 26659219 BACKGROUND

• 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.

  PMID: 25512630 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, Buffy Coat, Liver tissue (Core Needle Biopsy)

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Hepatitis C; Hepatitis B; Fibrosis; Fatty Liver; Pediatric Obesity; Liver Diseases; Obesity; Hepatitis

Condition Hierarchy (Ancestors)

Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepadnaviridae Infections; DNA Virus Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Andrew Talal, MD

  University at Buffalo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Bauer, BA

CONTACT

716-888-4825; bmbauer@buffalo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 19, 2017
• Study Start: July 1, 2013
• Primary Completion (Estimated): December 1, 2099
• Study Completion (Estimated): December 1, 2099
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)