Last updated on January 2019

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


Brief description of study

The goal of this clinical research study is to learn about testing patients for viral infections before chemotherapy. Researchers want to learn which patients are at higher risk for these infections so that, in the future, patients might be able to be tested more effectively.

Detailed Study Description

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.

Clinical Study Identifier: NCT01970254

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