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Trial record 114 of 324 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Biologic Basis of Liver Cancer From Chronic Hepatitis B

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ClinicalTrials.gov Identifier: NCT03300414
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Hepatitis B, Chronic Other: One time blood draw

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biologic Basis of Liver Cancer From Chronic Hepatitis B
Actual Study Start Date : March 20, 2017
Estimated Primary Completion Date : March 19, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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
Same as part 1
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.



Primary Outcome Measures :
  1. Associate viral sequences and host gene expression signatures with established HCC risk factors in Asian Americans. [ Time Frame: 1 year ]
    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).


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.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Asian Americans with co-infection of Chronic Hepatitis B with Hepatocellular Carcinoma
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Co-infection with hepatitis C virus (HCV) or HIV
  2. Use of immunosuppressive medications
  3. Inability to give informed consent
  4. Prisoners
  5. Pregnant women
  6. Cognitively impaired individuals or inability to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300414


Contacts
Contact: Chung-Heng Liu, BS 916-734-8985 chliu@ucdavis.edu
Contact: Eric W Chak, MD, MPH 916-7348696 echak@ucdavis.edu

Locations
United States, California
University of California, Davis Recruiting
Sacramento, California, United States, 95817
Contact: Chung-Heng Liu, BS    916-734-8985    chliu@ucdavis.edu   
Contact: sandeep S Dhaliwal, MD    9167348696    sandhaliwal@ucdavis.edu   
Principal Investigator: Eric W Chak, MD, MPH         
Sponsors and Collaborators
University of California, Davis

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03300414     History of Changes
Other Study ID Numbers: 959251
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Carcinoma, Hepatocellular
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Hepadnaviridae Infections
DNA Virus Infections