A Study of Molecular and Genetic Factors for Liver Cancer in the Greater Baltimore Area

Completed

Conditions studied: Carcinoma, Hepatocellular, Liver Cirrhosis, Alcoholic, Hepatitis, Alcoholic, Hepatitis, Chronic, Hepatitis, Viral, Human

In brief

Background: * Liver cancer is the third most deadly and fifth most common cancer worldwide. Hepatocellular carcinoma (HCC) is the most frequent primary liver cancer, and it has grown more prevalent in the United States. * More information is needed about the causes and effects of liver cancer, and further research into individuals who are at high risk for developing liver cancer is needed for early diagnosis and prevention. Objectives: * To identify genetic factors that may help to explain the aggressiveness of liver cancer. * To determine if HCC biomarkers exist in blood, urine, and tissue samples. Eligibility: * Patients between the ages of 18 and 90 who have been diagnosed with HCC or have a high risk for developing HCC because of fatty liver disease (alcohol-related or non-alcohol-related) or chronic hepatitis B or C. * Participants will reside in Baltimore City and the surrounding areas. Design: * Participants will complete a questionnaire and provide blood and urine samples for testing: * The questionnaire will include questions about individual and family medical history, tobacco use, and exposure to known factors for liver cancer. * Blood and urine samples will be collected from all participants after the questionnaire. * Tumor tissue and healthy tissue will be collected from selected participants if they undergo surgery for their cancer or disease. * No specific treatment will be offered as part of this protocol, but participants have the option to be treated under different protocols.

Key facts

Study ID

NCT00913757

Run by

National Cancer Institute (NCI)

People needed

1871

Starts

2009-07-01

Expected to finish

2020-05-01

Last updated by the study team

2020-05-04

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Exclusion Criteria-HCC CANCER CASES
• Liver cancer patients who are older than 90 years are excluded because of co-morbidity considerations and the difficulty of matching those cases with population-based controls.
• Children and institutionalized patients are excluded from the proposed study. Very few HCC patients at the 3 participating hospitals are younger than 18 years of age and HCC incidence mainly occurs in adults.
• Exclusion Criteria-HCC HIGH-RISK NON-CANCER CASES
• High Risk Non-Cancer patients who are older than 90 years are excluded because of co-morbidity considerations and the difficulty of matching those cases with population-based controls.
• Children and institutionalized patients are excluded from the proposed study. Very few HCC patients at the 3 participating hospitals are younger than 18 years of age and HCC incidence mainly occurs in adults. High-Risk Non-Cancer cases who are younger than 18 years are excluded due to the need of matching with HCC cases and population controls.
• Exclusion Criteria-POPULATION BASED CONTROLS
• Population based controls who are older than 90 years are excluded because of co-morbidity considerations and the difficulty of matching with HCC cases and high risk non-cancer cases.
• Population controls who are younger than 18 years or are institutionalized are excluded due to the need of matching with HCC cases and high-risk non-cancer cases.
• Population controls with prior cancer with the exception of non-melanomic skin cancer (squamous or basal cell).

Where it is running

• University of Maryland Medical Center — Baltimore, Maryland, United States
• Veterans Affairs Medical Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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