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Trial record 83 of 309 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Identification of Chronic Hepatitis B Infections Among Somali Immigrants in Minnesota Through Community-wide Screening

This study is currently recruiting participants.
Verified November 2015 by Lewis R. Roberts, Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT02366286
First Posted: February 19, 2015
Last Update Posted: November 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Gargar Urgent Care & Clinic
Axis Medical Center
Information provided by (Responsible Party):
Lewis R. Roberts, Mayo Clinic
  Purpose
The prevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) in the United States (US) is relatively low. However, immigrant populations in the US from Asia and sub-Saharan Africa have substantially higher prevalence than the general population and are consequently at a significant risk for hepatocellular carcinoma (HCC). Indeed, the age-adjusted incidence rates for HCC in the US have tripled from 1975 to 2005. As the population demographics have changed, the 2000 US census estimated the number of Somalis in Minnesota at 25,000 but current estimates put the number at around 50,000 due to primary refugee arrivals as well as secondary immigration from other states. There is no available data for Somali immigrants in the US on HBV and HCV prevalence, HBV and HCV genotypes/subgenotypes, and genetic and immunologic risk factors predisposing Somalis to HBV and HCV and the subsequent development of HCC. Therefore. this study will fill these gaps in the Somali population to understand the relative importance of HBV and HCV infections in causation of HCC.

Condition
Hepatitis B Hepatitis C Carcinoma, Hepatocellular

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Hepatitis B and Hepatitis C as Risk Factors for Hepatocellular Carcinoma in Somali Immigrants: Role of Viral Genetics and the Immune Response

Resource links provided by NLM:


Further study details as provided by Lewis R. Roberts, Mayo Clinic:

Primary Outcome Measures:
  • Number of subjects who test positive for markers of Hepatitis B Virus infection (HBsAg, HBcAb, HBsAb) [ Time Frame: 2 Years ]
  • Number of subjects who test positive for markers of Hepatitis C Virus infection (anti-HCV infection) [ Time Frame: 2 years ]
  • Rate of HBV vaccination in subjects with negative HBV serology [ Time Frame: 2 Years ]

Secondary Outcome Measures:
  • Incidence of HCC over the period of the study [ Time Frame: 2 Years ]

Biospecimen Retention:   Samples With DNA
A blood draw of 45 ml. will be taken for serum, plasma and buffy coat

Estimated Enrollment: 1000
Study Start Date: November 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Detailed Description:

Specific Aim 1: To recruit a cohort of Somali immigrants for screening for chronic HBV and and HCV infection and education on prevention and treatment of hepatitis B. The investigators will specifically:

  1. Establish a community-based program to recruit Somali African immigrant individuals in Minnesota for screening for hepatitis B and HCV
  2. Establish partnerships with Somali African community organizations and physicians to enhance screening and education about prevention and treatment of hepatitis B and HCV and their sequelae, including HCC.

Specific Aim 2: To characterize viral factors that contribute to chronic inflammation, cirrhosis and HCC in Somali immigrants. The investigators will specifically:

  1. Determine the HBV and HCV viral status of participants using serologic tests and viral load
  2. Determine the viral genotypes and viral mutations and their correlation to measures of liver injury, immune function, liver cirrhosis, and HCC.

Specific Aim 3: To characterize host factors that contribute to chronic inflammation, cirrhosis and HCC in Somali immigrants. The investigators will specifically:

  1. Determine whether variations in host immune phenotypes as measured by a novel multicolor flow cytometry assay correlate to clinical measures of inflammation, fibrosis, and HCC
  2. Determine whether variations in host genotypes in genes known to affect the liver disease phenotype correlate to measures of liver disease severity.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Somali immigrants and refugees in Minnesota
Criteria

Inclusion Criteria:

  • 18 years or older
  • Somali Descent

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

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): NCT02366286


Contacts
Contact: Nasra H. Giama, DNP, RN, PHN 507-538-0097 giama.nasra@mayo.edu
Contact: Lewis R. Roberts, MB ChB, PhD 507-538-4877 roberts.lewis@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Gargar Urgent Care & Clinic
Axis Medical Center
  More Information

Responsible Party: Lewis R. Roberts, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02366286     History of Changes
Other Study ID Numbers: 09-001670
IN-US-174-0230 ( Other Grant/Funding Number: Gilead )
First Submitted: October 8, 2014
First Posted: February 19, 2015
Last Update Posted: November 6, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis, Viral, Human
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site