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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Malignant Neoplasm; Hepatitis B Infection; Hepatitis B; Cancer; HBV

Treatments: Other: Hepatitis B Screening; Other: Survey Administration

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01970254

P30CA016672 (U.S. NIH Grant/Contract)

R21CA167202 (U.S. NIH Grant/Contract)

NCI-2019-02247 (Registry Identifier)

2012-0961 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,206 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,206 participants in 1 patient group

Screening (hepatitis B screening)

Description:

Patients with unknown HBV infection status undergo 3 HBV screening tests (HBsAg, anti-HBc, and 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.

Treatment:

Other: Survey Administration

Other: Hepatitis B Screening