Widespread vs. Selective Screening for Hepatitis B Infection Prior to Chemotherapy
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.
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 2015 (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
If patients agree to take part in this study, the following tests and procedures will be performed at a baseline visit:
- Blood (about 1 tablespoon) will be drawn to test for hepatitis B, C, and HIV. If this blood draw has been done within 90 days before enrollment, it will not be repeated.
- Patients will fill out questionnaires about their risk of having hepatitis B, C, and HIV. Patients will also answer questions about demographic information such as age, race, and sex. This should take about 10 minutes to complete.
If the tests show patients do not have hepatitis B, C, or HIV, they will be mailed a letter with the results of the testing.
If the questionnaire shows that patient may have had contact with someone who had hepatitis B, patient will receive further evaluation by medical staff in the Department of General Internal Medicine to determine whether patient 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.
If the tests show patient has hepatitis B, hepatitis C, or HIV, patient may have the following tests and procedures 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, patient will be asked about any side effects and symptoms they may have had.
If patients are found to have hepatitis B, C, or HIV, they will receive further evaluation by medical staff in the Departments of General Internal Medicine, Infectious Diseases, or Gastroenterology, Hepatology and Nutrition, to determine whether they need antiviral medication and further medical care during chemotherapy treatments.
For all participants, researchers may continue to check their medical records for up to 18 months after study enrollment or for up to 12 months after their chemotherapy treatment ends.
Length of Study:
If patients do not have one of these infections, their active study participation will be over after the baseline visit.
If patients have hepatitis B, hepatitis C, or HIV, they will remain on the study as long as they are benefiting, until 12 months after their chemotherapy treatment ends, or until the study closes. The study is expected to last about 18 months. If patients are still receiving chemotherapy when the study closes, they will have the option to continue with their care off of the study.
|Contact: Jessica P. Hwang, MD||713-745-4516|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Jessica P. Hwang, MD|
|Study Chair:||Jessica P. Hwang, MD||UT MD Anderson Cancer Center|