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

Inclusion Criteria

- INCLUSION CRITERIA:

SELECTION OF CASE SUBJECTS (HCC AND HIGH RISK NON-CANCER CASES)

We will recruit incident cases of pathologically confirmed primary liver cancer or risk
factors for liver cancer (patients with chronic liver disease due to hepatitis B and/or C
viral infection, nonalcoholic steatohepatitis or alcoholic cirrhosis) at all stages of the
disease that are age greater than or equal to 18 years or less than or equal to 90 years.
Treatment can be surgery or therapy. The following check list will be used to verify
eligibility of a case subject.

ELIGIBILITY CRITERIA- HCC CANCER CASES

1. Diagnosed with primary liver cancer (HCC) within the last two years

2. Physician diagnosis based on AFP and ultrasound/imaging or Pathological diagnosis of
primary liver cancer made at the local hospital pathology department

3. Resides in Maryland or surrounding states

4. Has a residential working phone within his/her home (*The reason for a participant
having a residential working phone is that the matching population controls are
selected through the Department of Motor Vehicles records and must have a residential
telephone number to be selected as part of the random sample.)

5. Age is greater than or equal to 18 years and less than or equal to 90 years

6. A non-objection statement by the physician from the hospital where the patient was
identified, or listed as the treating physician by the tumor registry or surgical
pathology report, to contact the patient is obtained

7. Is not currently residing in an institution, such as a prison, nursing home, or
shelter

8. Is not a severely ill patient in the intensive care unit

9. Is able to give informed consent

10. Is physically and mentally capable of performing the interview

11. Must understand English well enough to be interviewed

12. Has never been interviewed as a control for this study

13. Subject provides informed consent and signs form.

ELIGIBITY CRITERIA- HIGH RISK NON-CANCER CASES

1. Has been diagnosed with chronic Hepatitis B or C, NASH or alcoholic liver disease
with chronicity present at least for a 6 month period

2. Resides in Maryland or surrounding states

3. Has a residential working phone within his/her home

4. Age greater than or equal to 18 years and less than or equal to 90 years

5. A non-objection statement by the physician from the hospital where the patient was
identified or is being treated or by the surgical pathology report, to contact the
patient is obtained

6. Is not currently residing in an institution, such as a prison, nursing home, or
shelter

7. Is not a severely ill patient in the intensive care unit

8. Is able to give informed consent

9. Is physically and mentally capable of performing the interview

10. Must understand English well enough to be interviewed

11. Has never been interviewed as a control for this study

12. Subject provides informed consent and signs form.

SELECTION OF POPULATION-BASED CONTROLS

Population-based controls will be identified through the Motor Vehicle Administration
(MVA), and matched on age (year of birth), race, gender and geography to cases. We sample
controls in proportion to the population size of their county of residence. Recruitment of
controls will start concurrently with case accrual, using the age, race and gender
frequency distribution of cancer patients in previous years. The sampling frame is
continually updated as we accrue information on the case distribution of age, race and
gender. We will exclude controls that do not have a listed home phone number. The
following check list will be used to verify eligibility of a control subject.

ELIGIBILITY CRITERIA - POPULATION-BASED CONTROLS

1. Resides in Baltimore City, Anne Arundel, Baltimore, Caroline, Carroll, Cecil,
Dorchester, Harford, Howard, Kent, Queen Anne's, Somerset, Talbot, Wicomica and
Worchester County.

2. Has a residential working phone within his/her home

3. Age greater than or equal to 18 years and less than or equal 90 years

4. Have never had radiation therapy or chemotherapy

5. Is not currently residing in an institution, such as a prison, nursing home, or
shelter

6. Is physically and mentally capable of performing the interview

7. Must understand English well enough to be interviewed

8. Has never been interviewed as a control for the study

9. Subject provides informed consent and signs form.

EXCLUSION CRITERIA:

Exclusion Criteria-HCC CANCER CASES

1. 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.

2. 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

1. 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.

2. 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

1. 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.

2. Population controls who are younger than 18 years and are institutionalized are
excluded due to the need of matching with HCC cases and high-risk non-cancer cases.

3. Population controls with prior cancer with the exception of non-melanomic skin cancer
(squamous or basal cell).