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OpenTrials
Completed

NCT Number: NCT02358070

Epidemiologic Study of Hepatocellular Carcinoma in the US

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.

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Key information

Age range

35 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford Liver Transplant Clinic

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

for control subjects:

  • age < 35 years or > 84 years
  • temporary residents of New Jersey or Connecticut
  • unable to speak English or Spanish
  • cannot provide adequately comprehensible information

Treatment and study plan

Primary outcomes

  1. Lifetime physical activity

    Time frame: 20 years

    Lifetime 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.

  2. Energy intake

    Time frame: 20 years

    A 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.

  3. Lifestyle factors

    Time frame: 20 years

    Structured 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 6, 2015
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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