Hepatitis BNCT02366286
Hepatitis B and Hepatitis C as Risk Factors for Hepatocellular Carcinoma in African and Asian Immigrants
An observational study of Hepatitis B and Hepatitis C, run by Mayo Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Hepatitis C, Carcinoma, Hepatocellular
- How many people
- 892 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2010to 5 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: African and Southeast Asian immigrant and refugees
Who may be able to join
- 18 years or older
- African descent
- Southeast Asian descent
Who cannot join
- 17 years or younger
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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.
- Conditions
- Hepatitis B, Hepatitis C, Carcinoma, Hepatocellular
- Medical subject headings
- Hepatitis B, Hepatitis C, Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects who test positive for markers of Hepatitis B Virus infection (HBsAg, HBcAb, HBsAb)
Measured: 2 Years
Number of subjects who test positive for markers of Hepatitis C Virus infection (anti-HCV infection)
Measured: 2 years
Rate of HBV vaccination in subjects with negative HBV serology
Measured: 2 Years
Secondary outcomes (1)
Incidence of HCC over the period of the study
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study start27 Jul 2010
- Primary completion11 Sep 2017
- Study completion5 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 892 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Gargar Clinic, Axis Medical Center
- Responsible party
- Sponsor
- Investigators
- Lewis R. Roberts, MB ChB, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366286
- Sponsor's protocol ID
- 09-001670
- Other IDs
- IN-US-174-0230
- Status last verified
- Dec 2023
- First submitted
- 8 Oct 2014
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02366286
- Acronym / sponsor ID
- 09-001670
- Conditions
- Hepatitis B, Hepatitis C, Carcinoma, Hepatocellular
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 892 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Gargar Clinic, Axis Medical Center
- Study start
- 27 Jul 2010 (actual)
- Primary completion
- 11 Sep 2017 (actual)
- Study completion
- 5 Oct 2017 (actual)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- African and Southeast Asian immigrant and refugees
Key inclusion criteria (3 listed)
- 18 years or older
- African descent
- Southeast Asian descent
Key exclusion criteria (1 listed)
- 17 years or younger
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Incidence of HCC over the period of the study
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lewis R. Roberts, MB ChB, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B and Hepatitis C, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects who test positive for markers of Hepatitis B Virus infection (HBsAg, HBcAb, HBsAb) (time frame: 2 Years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.