Epidemiologic Study of Hepatocellular Carcinoma in the US

Hepatocellular Carcinoma Clinical Trial

Official title:

Epidemiologic Study of Hepatocellular Carcinoma in the US

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358070
• Other study ID #: HEP0049
• Status: Completed
• Start date: April 2015
• Est. completion date: September 1, 2016

Study information

• Verified date: March 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 1, 2016
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
United States	Stanford Liver Transplant Clinic	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lifetime physical activity	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.	20 years
Primary	Energy intake	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.	20 years
Primary	Lifestyle factors	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.	20 years