Blood Collection Biorepository for Liver Disease Research | NCT03025074

Studies
Blood Collection Biorepository for Liver Disease Research

NCT03025074

Sponsor

State University of New York at Buffalo

Status

Recruiting

Last Update Posted

Aug 27, 2025Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Dec 2099Estimated

Completion Date

Dec 2099Estimated

First Submitted Date

Jan 16, 2017

First Submission Date that Met QC Criteria

Jan 18, 2017

First Posted Date

Jan 19, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2025

Last Update Posted Date

Aug 27, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrew Talal, Professor of Medicine, State University of New York at BuffaloPrincipal Investigator

Lead Sponsor

State University of New York at BuffaloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of samples collected	Total number of samples collected	52 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Barbara Bauer, BA	Contact	716-888-4825		bmbauer@buffalo.edu

Overall Officials

Name	Affiliation	Role
Andrew Talal, MD	University at Buffalo	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University at Buffalo, Buffalo General Medical Center	Recruiting	Buffalo	New York	14203	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27685683	Background	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.
27527820	Background

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D006526	Hepatitis C
D006509	Hepatitis B
D005355	Fibrosis
D005234	Fatty Liver
D063766	Pediatric Obesity
D008107	Liver Diseases
D009765	Obesity
D006505	Hepatitis

ID	Term
D004066	Digestive System Diseases
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections