Genes Involved in Resistance or Susceptibility to Hepatitis B Virus

NCT00342186 | Completed

• 2 other identifiers: 99990232302-C-N323
• Study Type: observational
• Target: 2,303
• Locations: 1 country
• Sites: 1

Brief Summary

This study, conducted by the Beijing University First Hospital of China and the National Cancer (NCI), will try to identify genes associated with either susceptibility or resistance to chronic infection by the hepatitis B virus (HBV). Some people recover from HBV infection; others become chronically infected and may go on to develop severe liver disease such as cirrhosis or liver cancer. About 350 million people worldwide have chronic HBV infection. Of 120 million infected Chinese, 90 percent of children infected at less than 5 years of age and 10 percent of infected adults develop persistent infection. HBV-infected and non-infected healthy persons of Han ethnicity born before 1963 may be eligible for this study. Offspring of infected candidates (born in any year) may also be enrolled. Infected adults must have at least one infected parent or sibling. Persons who resided in Fusui County of Guangxi Zhuang Autonomous Region or in the Qidong district of Jiangsu Province for at least 6 months before 1986 may not participate. All participants (except offspring of the study subjects) will fill out a health questionnaire (providing information about eating, drinking, and smoking habits and a personal and family health history) and will donate no more than 20 milliliters of blood. The blood will be tested for antibodies, antigens, and other substances that may indicate infection with hepatitis viruses. Some of the blood will be sent to the NCI for DNA analysis to identify genetic factors that may influence clearance of the hepatitis virus after infection or progression to liver diseases associated with HBV infection. Infected patients who have had a liver biopsy in the past will be asked permission to examine tissue from the biopsy and to review laboratory results of any tests done for diagnostic and treatment purposes. When the study is completed, specimens sent to the NCI will have identifiers linking the material to the donor removed. The anonymous samples may then be used for other genetic studies. Specimens remaining in China will continue to have identifiers linked to them and may be used for future studies designed to identify who is at greatest risk of developing serious liver diseases. Participants who do not want their blood used for future studies may request that the samples be destroyed. Because children inherit one-half of their DNA from each parent, DNA samples from HBV infected study participants may provide additional information about the parent s DNA structure. Offspring who participate in this study will provide a DNA sample. The sample is obtained by swishing a mouthwash in the mouth for 30 seconds and then spitting the mouth wash into a cup. The DNA is then isolated from the mouth cells.

Conditions

Hepatitis, Viral, Human

Keywords

China; Cancer; Hepatitis B; Genetics; Liver Disease; HBV

Outcome Measures

Primary Outcomes (1)

• Collection of 3400 samples

  genotyping study

  Annual

Eligibility Criteria

• Age: 8 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy donors and those infected with HBV

You may qualify if:

• A Group - HBV Clearance:
• HBsAg negative and anti-HBs and anti-HBc positive or anti-HBs positive and no HB Vaccination history.
• No systemic diseases.
• B Group - Asymptomatic persistent infection:
• HBsAg, anti-HBc positive for at least 6 months.
• At least one parent or sibling HBsAG positive .
• ALT and AST have been in normal range (less than 45 IU/L) at least 5 years
• No clinical symptoms of hepatitis.
• No clinical liver cirrhosis.
• C Group - Chronic Hepatitis B:
• HBsAg, anti-HBc positive for more than 6 months.
• At least one parent or sibling HBsAg positive.
• ALT and/or AST were greater than or equal to 60 IU/L or greater than 2 times upper limit of normal.
• No clinical liver cirrhosis.
• No other systemic diseases.

You may not qualify if:

• B thru E Groups:
• Persons born in 1963 or later.
• Persons not of Han ethnicity.
• Persons with no first-order relative (parent or sibling) with HBV infection.
• Persons who resided in Fusui County of Guangzi Zhuang Autonomous Region or in the Qidong district of Jiangsu Province for at least 6 months prior to 1986.
• anti-HCV, HCV RNA, anti-HDV, and/or HDAg.
• Current infection with HAV or HEV (indicated by antibodies and abnormal liver function).
• A \& F Groups - HBV Clearance \& Normal Donors:
• Persons born in 1963 or later.
• Persons not of Han ethnicity.
• Persons who resided in Fusui County of Guangxi Zhuang Autonomous Region or in the Qidong district of Jiangsu Province for at least 6 months prior to 1986.
• Anti-HCV, HCV RNA, anti-HDV and/or HGAg positive.
• Current infection with HAV or HEV (indicated by antibodies and abnormal liver function).

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Peking University First Hospital

Beijing, China

Location

Related Publications (3)

• Risch N, Merikangas K. The future of genetic studies of complex human diseases. Science. 1996 Sep 13;273(5281):1516-7. doi: 10.1126/science.273.5281.1516. No abstract available.

  PMID: 8801636 BACKGROUND

• O'Brien SJ, Nelson GW, Winkler CA, Smith MW. Polygenic and multifactorial disease gene association in man: Lessons from AIDS. Annu Rev Genet. 2000;34:563-591. doi: 10.1146/annurev.genet.34.1.563.

  PMID: 11092839 BACKGROUND

• Chisari FV. Cytotoxic T cells and viral hepatitis. J Clin Invest. 1997 Apr 1;99(7):1472-7. doi: 10.1172/JCI119308. No abstract available.

  PMID: 9119989 BACKGROUND

MeSH Terms

Conditions

Hepatitis, Viral, Human; Neoplasms; Hepatitis B; Liver Diseases

Condition Hierarchy (Ancestors)

Virus Diseases; Infections; Hepatitis; Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections

Study Officials

• Daniel W McVicar, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: September 27, 2002
• Primary Completion: February 22, 2018
• Study Completion: February 22, 2018
• Last Updated: June 16, 2020

Record last verified: 2020-06

Locations

CN (1)