<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03025074</url>
  </required_header>
  <id_info>
    <org_study_id>Biobank Blood</org_study_id>
    <nct_id>NCT03025074</nct_id>
  </id_info>
  <brief_title>Blood Collection Biorepository for Liver Disease Research</brief_title>
  <official_title>Virology, Immunology and Mechanisms of Liver Disease in Patients With Hepatitis C and Other Liver Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York at Buffalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State University of New York at Buffalo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of establishing a biorepository is to provide high quality specimens (serum,&#xD;
      plasma, buffy coat and liver tissue) for future researchers who are studying the effects that&#xD;
      fatty liver and viral diseases have on the liver.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Biorepository at the University at Buffalo has been established to collect biological&#xD;
      samples from patients with various types of liver disease. The objectives of this&#xD;
      biorepository are to stimulate collaboration between clinicians and researchers, to bolster&#xD;
      training of junior investigators and to promote multidisciplinary integration to advance&#xD;
      translational medicine and to improve the health of patients all over the country. The&#xD;
      purpose of this biorepository is to support investigators and to provide them with high&#xD;
      quality specimens to promote their efforts in new discoveries or perfecting treatment of&#xD;
      patients with liver diseases caused by Non-Alcoholic Fatty Liver Disease (NAFLD),&#xD;
      Non-Alcoholic Steatohepatitis (NASH), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and&#xD;
      Human Immunodeficiency Virus (HIV). The goal is to obtain samples that represent patients&#xD;
      seen in the clinics of medical centers in Western NY and from some of the rarer diseases&#xD;
      encountered in these clinics. The ultimate goal is to develop the biorepository as Western&#xD;
      New York's resource for clinically annotated human samples that can be used to conduct&#xD;
      research that could lead to significant advances in patient care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">December 2099</completion_date>
  <primary_completion_date type="Anticipated">December 2099</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Number of samples collected</measure>
    <time_frame>52 weeks</time_frame>
    <description>Total number of samples collected</description>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Non-Alcoholic Steatohepatitis(NASH)</condition>
  <condition>Hepatitis C</condition>
  <condition>Hepatitis B</condition>
  <condition>Fibrosis</condition>
  <condition>Cirrhosis</condition>
  <condition>Fatty Liver</condition>
  <condition>Obesity, Childhood</condition>
  <condition>Bariatric Surgery Candidate</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum, Plasma, Buffy Coat, Liver tissue (Core Needle Biopsy)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with NASH, NAFLD, Fibrosis, Cirrhosis, Hepatitis B or C, HIV or any form of Liver&#xD;
        Disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  This protocol is to establish a biobank of blood samples from individuals with or&#xD;
             without liver diseases including viral hepatitis, liver cancer, NASH, and negative&#xD;
             control samples.&#xD;
&#xD;
          -  Children and teenagers will be special populations considered in this protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vulnerable populations such as adults unable to consent, infants, pregnant women or&#xD;
             prisoners will not be considered for this research study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Talal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University at Buffalo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Barbara Bauer, BA</last_name>
    <phone>716-888-4825</phone>
    <email>bmbauer@buffalo.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University at Buffalo, Buffalo General Medical Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barbara Bauer, BA</last_name>
      <phone>716-888-4825</phone>
      <email>bmbauer@buffalo.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>27685683</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27527820</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27485356</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27277877</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26881485</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26877758</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26659219</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25512630</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of New York at Buffalo</investigator_affiliation>
    <investigator_full_name>Andrew Talal</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Liver Disease</keyword>
  <keyword>Obesity</keyword>
  <keyword>Hepatitis</keyword>
  <keyword>HIV</keyword>
  <keyword>Hepatology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Biorepository was created to provide high quality specimens to future researchers to advance their clinical and translational research.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03025074
org study id: Biobank Blood
nct id: NCT03025074
lead sponsor: 
has dmc: Yes
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.
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: Number of samples collected
time frame: 52 weeks
description: Total number of samples collected
Serum, Plasma, Buffy Coat, Liver tissue (Core Needle Biopsy)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew Talal, MD
role: Principal Investigator
affiliation: University at Buffalo
last name: Barbara Bauer, BA
phone: 716-888-4825
email: bmbauer@buffalo.edu
facility: 
status: Recruiting
contact: 
country: United States
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Principal Investigator
investigator affiliation: State University of New York at Buffalo
investigator full name: Andrew Talal
investigator title: Professor of Medicine
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis B
mesh term: Hepatitis
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Pediatric Obesity
sharing ipd: Yes
ipd description: The Biorepository was created to provide high quality specimens to future researchers to advance their clinical and translational research.