Widespread vs. Selective Screening for Hepatitis B Infection Prior to Chemotherapy

Enrollment Visit:

If you agree to take part in this study, the following tests and procedures will be performed
at an enrollment visit:

- Blood (about 1 tablespoon) will be drawn to test for hepatitis B, C, and HIV. However,
if you are scheduled for a blood draw in the next 1-2 months, this can be done at that
time. If this blood draw has been done within 90 days before enrollment, it will not be
repeated.

- You will fill out questionnaires about your risk of having hepatitis B, C, and HIV. You
will also answer questions about your demographic information such as your age, race,
and sex. This should take about 10 minutes to complete.

- If your cancer doctor asks for information about your enrollment in the study, this will
be provided to your cancer team.

Study Visit:

If the tests show you do not have hepatitis B, C, or HIV infection, you will be mailed a
letter with the results of the testing.

If you are found to have hepatitis B, C, or HIV infection, the study staff will contact you
and your cancer doctor. You will receive further evaluation by medical staff in the
Departments of General Internal Medicine, Infectious Diseases, or Gastroenterology,
Hepatology and Nutrition, to determine whether you need antiviral medication and further
medical care during chemotherapy treatments. The study staff will inform your cancer doctor
if you need antiviral medication. The study staff will work closely with your cancer
doctor(s) to avoid any delays in treatment.

You may have the following tests and procedures at a baseline visit (about 4 weeks after
enrollment) and at Months 3, 6, 9, 12, 15, and 18 (+/- 4 weeks):

- If it has not been done in the last 2 weeks, blood (about 1-2 tablespoons) will be drawn
for routine tests and to test for hepatitis B.

- If the doctor thinks it is needed, you will be asked about any side effects and symptoms
you may have had.

If the questionnaire shows that you may have had contact with someone who had hepatitis B,
you may be contacted for further evaluation by medical staff in the Department of General
Internal Medicine to determine whether you need further medical care during chemotherapy
treatments. If the doctor thinks it is needed, blood (about 1-2 tablespoons) will be drawn
for follow-up tests.

Length of Study:

If you do not have one of these infections, your active study participation will be over
after the baseline visit.

If you have hepatitis B, hepatitis C, or HIV infection, you will remain on the study as long
as you are benefiting, until 12 months after your chemotherapy treatment ends, or until the
study closes. Researchers may continue to check your medical record for up to 18 months after
study enrollment or for up to 12 months after your chemotherapy treatment ends. If you are
still receiving chemotherapy when the study closes, you will have the option to continue with
your care off of the study.

This is an investigational study. Researchers are investigating whether all patients or
selective patients should be tested for hepatitis B, C, and HIV.

Up to 3,441 participants will be enrolled in this study. All will take part at MD Anderson.

Inclusion Criteria:

1. UNKNOWN HBV INFECTION STATUS/ KNOWN HBV INFECTION STATUS MD Anderson patients with
clinically confirmed cancer who present for their first chemotherapy appointment in
the Ambulatory Treatment Center (ATC).

2. UNKNOWN HBV INFECTION STATUS/ KNOWN HBV INFECTION STATUS Patients >/= 18 years of age.
(Patients < 18 years of age have low risk of HBV infection due to mandatory HBV
vaccinations at birth.)

3. KNOWN HBV INFECTION STATUS Patients with evidence of HBV infection by either: a.
Patients who have had a positive HBsAg or anti-HBc test performed outside of MD
Anderson within the last 3 months, and they have documented results in the electronic
medical record at MD Anderson or, AND/OR b. Patients currently taking a medication
(e.g., lamivudine, entecavir, tenofovir, adefovir, telbivudine, interferon, or other
FDA-approved anti-hepatitis B drug) for the treatment of HBV infection.

Exclusion Criteria:

1. UNKNOWN HBV INFECTION STATUS Patients who have had a positive HBsAg or anti-HBc test
performed outside of MD Anderson within the last 3 months, and they have documented
results in the electronic medical record at MD Anderson.

2. UNKNOWN HBV INFECTION STATUS Patients currently taking a medication (e.g., lamivudine,
entecavir, tenofovir, adefovir, telbivudine, interferon, or other FDA-approved
anti-hepatitis B drug) for the treatment of HBV infection.

3. KNOWN HBV INFECTION STATUS Exclusion: None