NCT01970254

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,206 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Cancer
• Hepatitis B
• HBV
• Hepatitis B Infection
• Malignant Neoplasm

Interventions

Type	Name	Description
OTHER	Hepatitis B Screening	Undergo 3 HBV screening tests (HbsAg, anti-HBc, and anti-HBs)
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2013-06-24
• Primary completion: 2022-07-19
• Completion: 2022-07-19
• First posted: 2013-10-28
• Last updated: 2022-08-15

Locations

1 site across 1 country: United States