Biologic Basis of Liver Cancer From Chronic Hepatitis B

NCT03300414 | Completed

• 1 other identifier: 959251
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The focus of the study is to identify viral factors and host immune responses that differentiate HBV-related HCC patients from HBV patients who have not progressed to HCC. To that end, the investigators will compare gene expression levels between HCC patients and non-HCC patients categorized into high and low risk profiles. The investigators will perform ANOVA to compare three groups (HCC, high risk, low risk). Multiple comparison corrections will be performed using Benjamini and Hochberg False Discovery Rate (FDR) with a 90% confidence that the discovery lists will contain no more than 5% false positives (FDR\<0.05) (PMID: 12584122, 11682119). A p-value \<0.05 is considered statistically significant using this multiple comparison correction approach. Post-hoc Student-Newman-Keuls or Tukey tests will be used following ANOVA for comparisons of HCC patients with high risk and low risk. If data are not normally distributed when log-transformed, then Kruskall-Wallis tests will be used. ANCOVA will be used to adjust for the effects of covariates, such as age, gender, and HBV genotype (B or C). Further, the investigators often use an additional 2-fold change criterion for significance because the investigators consider a fold change of this magnitude to be biologically significant. Hierarchical clustering analyses and principal component analyses will be used to visualize how well the genes separate the groups, or to discover new subgroups. For the analysis of SNVs, the exact binomial test will be performed and p-values will be adjusted by the Benjamini-Hochberg correction.

Conditions

Hepatocellular Carcinoma; Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• Associate viral sequences and host gene expression signatures with established HCC risk factors in Asian Americans.

  In order to meet this aim, blood samples will be obtained from 10 consented subjects. The DNA extracted from these samples will be used as part of an ongoing study comparing viral sequences and gene expression profiles across Asian ethnic groups, we will analyze the same data comparing individuals with high and low HCC risk factors (i.e. the presence and absence of cirrhosis, high HBV viral load, men who have sex with men).

  1 year

Study Arms (2)

Collection of blood specimen

Collection of blood specimen from patients will be performed during the course of routine medical care at UC Davis with no prospective follow up period. The duration anticipated to enroll all 10 study subjects will be 1 year. The estimated date for the investigator to complete analysis and publication is 2 years.

Other: One time blood draw

Liver Biopsy slides

Up to twenty (20) de-identified hepatocellular carcinoma (HCC) tissue sections on biopsy slides or frozen sections and associated information such as age, sex, race, ethnicity, treatment status, pathological diagnoses, and date of procedure will be obtained from UC Davis Cancer Center Biorepository (CCB) and outside tissue biobanks, including, but not limited to, Cooperative Human Tissue Network (CHTN). The duration anticipated to complete analysis and publication is 2 years.

Interventions

One time blood draw OTHER

Same as part 1

Collection of blood specimen

Eligibility Criteria

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

Study Population

Asian Americans with co-infection of Chronic Hepatitis B with Hepatocellular Carcinoma

You may qualify if:

• Asian Americans
• Aged 18 years or older with a confirmed diagnosis of HCC and liver cancer from chronic hepatitis B.
• The diagnosis of liver cancer can be made with by meeting radiologic criteria for HCC or liver histology obtained through liver biopsy.

You may not qualify if:

• Co-infection with hepatitis C virus (HCV) or HIV
• Use of immunosuppressive medications
• Inability to give informed consent
• Prisoners
• Pregnant women
• Cognitively impaired individuals or inability to provide informed consent

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Approximately 30mL (2 tablespoons) of venous blood may be collected. A second blood draw may occur if the first is inadequate in quantity or quality. However, the second blood draw will not occur until eight (8) weeks following the first blood draw. In other words, no more than 50mL of venous blood may be collected in a period of eight (8) weeks. Blood samples will be labeled with the patient assigned ID by the study coordinator before distributing to UC Davis Cancer Center's Shared Genome Resource Center for DNA and/or RNA isolation.

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 3, 2017
• Study Start: March 20, 2017
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)