Hepatitis B and Hepatitis C as Risk Factors for Hepatocellular Carcinoma in African and Asian Immigrants
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 1000
Summary
- Conditions
- Carcinoma, Hepatocellular
- Hepatitis B
- Hepatitis C
- Type
- Observational
- Design
- Observational Model: Ecologic or CommunityTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT02366286
- Collaborators
- Gargar Clinic
- Axis Medical Center
- Investigators
- Principal Investigator: Lewis R. Roberts, MB ChB, PhD Mayo Clinic