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

N/ACompletedNCT01970254

M.D. Anderson Cancer Center2,206 enrolled

Overview

This trial studies hepatitis B screening strategies of new cancer patients scheduled to undergo chemotherapy. Patients with cancer and hepatitis B virus infection are at risk of reactivation of infection after chemotherapy. Hepatitis B virus infection reactivation can be prevented by starting antivirals before chemotherapy in patients who are hepatitis B virus infection positive. Hepatitis B screening may help doctors prevent the reactivation of hepatitis B virus infection after chemotherapy.

PRIMARY OBJECTIVES: I. To derive a selective screening strategy that optimizes the identification of positive hepatitis B virus (HBV) infection cases in comparison to widespread screening of new cancer patients undergoing chemotherapy. SECONDARY OBJECTIVES: I. To determine the prevalence of risk factors among patients with unknown HBV infection status as well as among patients known to have HBV infection, determine the incidence of reactivation of hepatitis B virus (HBV) infection, rates of disruptions in cancer therapy, co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV), and mortality rates. OUTLINE: Patients with unknown HBV infection status undergo 3 HBV screening tests (hepatitis B surface antigen \[HBsAg\], hepatitis B core antibody \[anti-HBc\], and hepatitis B surface antibody \[anti-HBs\]) before chemotherapy. Patients with known HBV infection status undergo either HBsAg or anti-HBc screening tests if there is no evidence of HBV testing in the last 3 months. All patients complete HBV risk assessment survey. After completion of study, patients with HBV infection are followed up every 3 months for at least 12 months after completion of chemotherapy or end of study period.

Study Type

OBSERVATIONAL

Enrollment

2,206

Conditions

Cancer Hepatitis B

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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). * KNOWN HBV INFECTION STATUS: Patients with evidence of HBV infection by either: * 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, AND/OR * Patients currently taking a medication (e.g., lamivudine, entecavir, tenofovir, adefovir, telbivudine, interferon, or other Federal Drug Administration \[FDA\]-approved anti-hepatitis B drug) for the treatment of HBV infection. Exclusion Criteria: * 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. * 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.

Outcomes

Primary Outcomes

Rate of a positive result (hepatitis B surface antigen [HBsAg], hepatitis B core antibody [anti-HBc], and hepatitis B surface antibody [anti-HBs]) before first chemotherapy

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.

Time frame: Baseline blood tests, approximately 30 minutes for blood draw