Widespread vs. Selective Screening for Hepatitis B Infection Prior to Chemotherapy
Other: HBV screening tests
Behavioral: HBV risk assessment survey
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Widespread Versus Selective Screening for Hepatitis B Infection Prior to Chemotherapy|
- Rate of a positive result (HBsAg, anti-HBc, and anti-HBs) before first chemotherapy [ Time Frame: Baseline blood tests, approximately 30 minutes for blood draw ] [ Designated as safety issue: No ]Number of screened participants (new cancer patients undergoing chemotherapy) with positive hepatitis B virus (HBV) infection compared to total screened. Prospective, universal screening of eligible MD Anderson cancer patients not known to have HBV infection using three HBV screening tests (HBsAg,anti-HBc,and anti-HBs) prior to chemotherapy.
|Study Start Date:||June 2013|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Hepatitis B Screening
Testing for positive hepatitis B virus (HBV) infection before chemotherapy using three HBV screening tests (HBsAg,anti-HBc,and anti-HBs) and survey completion.
Other: HBV screening tests
Three (3) hepatitis B virus (HBV) infection tests: HBsAg, anti-HBc, and anti-HBsBehavioral: HBV risk assessment survey
Estimated time to complete the HBV risk assessment tool is 5 minutes.
Other Name: Questionnaire
Hide Detailed Description
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01970254
|Contact: Jessica P. Hwang, MD||713-745-4516|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Jessica P. Hwang, MD|
|Study Chair:||Jessica P. Hwang, MD||M.D. Anderson Cancer Center|