Epidemiologic Study of Hepatocellular Carcinoma in the US

NCT02358070 | Completed

• 1 other identifier: HEP0049
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

HCC group

control group

Eligibility Criteria

• Age: 35 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with Hepatocellular Carcinoma in New Jersey and Connecticut as well as selected patients in New York, Hawaii and northern California. Healthy volunteers will comprise a random sample of New Jersey and Connecticut residents as controls.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Liver Transplant Clinic

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva samples

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Mindie Nguyen, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 6, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

US (1)