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Epidemiologic Study of Hepatocellular Carcinoma in the US

Epidemiologic Study of Hepatocellular Carcinoma in the US

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02358070
Enrollment
45
Registered
2015-02-06
Start date
2015-04-30
Completion date
2016-09-01
Last updated
2020-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma

Brief summary

The purpose of this study is: * to investigate the risk factors of HCC among Americans with focus on lifestyle factors and energy balance. * to identify single nucleotide polymorphisms (SNPs) and haplotypes that are associated with HCC risk through a genome-wide search. * to assess if genetic susceptibility differs by hepatitis virus infection or lifestyle factors, and to explore if there are interplays or effect modifications between genetic factors and viral infection or lifestyle factors.

Interventions

None listed

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
35 Years to 84 Years
Healthy volunteers
Yes

Inclusion criteria

for HCC cases: * a diagnosis of primary liver cancer (excluding secondary tumors) * a diagnosis of hepatocellular carcinoma if histology is available (excluding those diagnosed in intrahepatic bile duct, bile canals, biliary passages, canaliculi, gall duct and gallbladder) * a diagnosis of hepatocellular carcinoma with or without microscopic evaluation (including those diagnosed with clinical evidence, lab tests and direct visualization or radiographic and other imaging evidence) * a histology of primary hepatocellular carcinoma when the patients had a prior diagnosis of other forms of cancer (excluding those who had no histological diagnosis of hepatocellular carcinoma while having a prior history of other cancer; * age at diagnosis between 35 and 84 years * living in Connecticut, New Jersey, New York, or Hawaii for at least a year as regular residents.

Exclusion criteria

for HCC cases: * uncertain diagnoses or classification of malignancy, such as unknown origin * a diagnosis of primary tumors in other organs, not in the liver * unable to communicate well enough in English or Spanish * having medical conditions, such as mental disorders, that prevent the subject from providing reasonably comprehensible information or from being able to give informed consent. * diagnosed at age \<35 years or \>84 years * temporary residents of New Jersey, Connecticut, New York, or Hawaii Inclusion Criteria for control subjects: * age between 35 and 84 years * living in New Jersey or Connecticut for at least a year as regular residents * able to communicate well in English or Spanish * having no medical conditions, such as mental disorders, that prevent them from providing adequately comprehensible information * potential subjects with a previous history of cancer are eligible.

Design outcomes

Primary

MeasureTime frameDescription
Lifetime physical activity20 yearsLifetime physical activity will be measured by collecting data on major types of physical activity separately and by determining frequency, intensity, and duration of each activity using a combined modification of Friedenreich's lifetime physical activity questionnaire and Kriska's past year physical activity questionnaires.
Energy intake20 yearsA modified Food Frequency questionnaire based on one developed by Dr. Alan Kristal from the Fred Hutchinson Cancer Research Center (FHCRC) in Seattle will capture energy intake by differentiating low-fat food options from higher-fat counterparts.
Lifestyle factors20 yearsStructured questionnaires will be used to elicit information on demographic, anthropometric, and socioeconomic factors, long-term use of medications, medical history, and family history of cancer, cigarette smoking and alcohol consumption, physical activity, and dietary habits. Additional information unrelated to liver cancer will be included in the questionnaire to help assess possible recall bias.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026