Expired Study
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Rochester, Minnesota 55905


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. Besides Somalis, Minnesota is also home to large other African immigrant communities. According to the Minnesota Department of Health (MDH), in 2013, the highest rates of chronic HBV cases where reported among Asian or Pacific Islanders (3,638 cases per 100,000 persons) followed by Black or African Americans (2,078 cases per 100,000 persons). Additionally, Minnesota receives a large number of new refugee's resettlement. It is important to improve the identification of chronic HBV and HCV infections among Somali refugees and immigrants in Minnesota through well-designed community-wide screening efforts. Since we know that African immigration to Minnesota is the third highest in the US, this unique population might be a contributing factor to the increased burden of hepatitis and liver cancer complications in the state of Minnesota. Findings from HBV and HCV screening among Somalis suggest that other immigrant African populations from high viral hepatitis endemic regions, such Ethiopia, Liberia, and Kenya, are also at substantial risk of HBV, HCV and HCC. Unfortunately, very little research has been conducted in the US on the burden of hepatitis and liver cancer in African Immigrants from areas of high endemicity of hepatitis B and hepatitis C. Therefore, the goal of is to identify HBV and HCV and the role viral genetics and immune response among African immigrant communities from Kenya, Liberia, and Ethiopia.


Study summary:

Specific Aim 1: We will determine whether exposures to HBV and HCV infections in African (Somalis, Kenyans, Liberians, and Ethiopians) and Southeast Asian (Hmong, Vietnamese, Laotian, and Cambodian) are associated with a single HBV/HCV genotype or few specific subtypes. In the following Sub-Aims we will: - confirm the viral status of study subjects using serological and DNA tests including HBsAg, HBcAb, anti-HCV, HBV DNA and HCV RNA. - perform nucleic acid testing to identify the HBV and HCV genotypes/sub-genotypes for each patient - examine the presence of either common or unique HBV and HCV viral mutations Specific Aim 2: We will determine whether African (Somalis, Kenyans, Liberians, and Ethiopians) and Southeast Asian (Hmong, Vietnamese, Laotian, and Cambodian) exposed to HBV or HCV have unique TLR or Treg immune signatures as compared to control subjects free from both HBV and HCV infections. In the following Sub-Aims we will: - measure the expression levels of toll-like receptors (in monocytes) of the host innate immune response to assess whether the expression of TLR differs between those exposed to HBV vs HCV - measure the circulating Tregs of the host adaptive immune response to determine whether the abundance of Treg differs between those exposed to HBV vs HCV Specific Aim 3: To determine whether genetic variation of IL28B (assessed by single nucleotide polymorphisms, rs12979860 and others) is associated with HCV treatment outcome in Somalis. - We will perform SNP analysis of IL28B in lymphocyte DNA in 60 HCV cases, 60 HBV and HCV cases and 60 healthy controls (this group and additional 60 HBV cases alone will provide baseline SNP frequencies in the Somali population), all the 240 subjects of the study will be tested for this SNP - We will measure treatment outcome using virological response by comparing pre-treatment viral load and post-treatment viral load in HCV case Aim 4: To recruit a cohort of African (Somalis, Kenyans, Liberians, and Ethiopians) and Southeast Asian (Hmong, Vietnamese, Laotian, and Cambodian)immigrants for screening for chronic HBV infection and education on prevention and treatment of hepatitis B. We will specifically: - Establish a community-based program to recruit African and Southeast Asian individuals in Minnesota for screening for hepatitis B and hepatitis C - Establish partnerships with African and Southeast Asian community organizations and physicians to enhance screening and education about prevention and treatment of hepatitis B, hepatitis C and its sequelae, including HCC.


Criteria:

Inclusion Criteria: - 18 years or older - African descent - Southeast Asian descent Exclusion Criteria: - 17 years or younger


Study is Available At:


Original ID:

09-001670


NCT ID:

NCT02366286


Secondary ID:

IN-US-174-0230


Study Acronym:


Brief Title:

Hepatitis B and Hepatitis C as Risk Factors for Hepatocellular Carcinoma in African and Asian Immigrants


Official Title:

Hepatitis B and Hepatitis C as Risk Factors for Hepatocellular Carcinoma in African and Asian Immigrants: Role of Viral Genetics and the Immune Response


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mayo Clinic


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

892


Enrollment Type:

Actual


Overall Contact Information

Official Name:Lewis R. Roberts, MB ChB, PhD
Principal Investigator
Mayo Clinic

Study Dates

Start Date:November 2010
Completion Date:December 2022
Completion Type:Anticipated
Primary Completion Date:December 2022
Primary Completion Type:Anticipated
Verification Date:January 2019
Last Changed Date:January 31, 2019
First Received Date:October 8, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Incidence of HCC over the period of the study
Time Frame:2 Years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Rate of HBV vaccination in subjects with negative HBV serology
Time Frame:2 Years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Number of subjects who test positive for markers of Hepatitis C Virus infection (anti-HCV infection)
Time Frame:2 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Number of subjects who test positive for markers of Hepatitis B Virus infection (HBsAg, HBcAb, HBsAb)
Time Frame:2 Years
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Mayo Clinic
Agency Class:Other
Agency Type:Collaborator
Agency Name:Gargar Urgent Care & Clinic

Samples and Retentions

Sample Retention:Samples With DNA
Description: A blood draw of 45 ml. will be taken for serum, plasma and buffy coat
Study Population: African and Southeast Asian immigrant and refugees
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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