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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970254
• Other study ID #: 2012-0961
• Secondary ID: NCI-2019-0224720
• Status: Completed
• Start date: June 24, 2013
• Est. completion date: July 19, 2022

Study information

• Verified date: August 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2206
• Est. completion date: July 19, 2022
• Est. primary completion date: July 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Communicable Diseases
• HBV
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Infection
• Infections
• Malignant Neoplasm
• Neoplasms

Intervention

Other:
• Hepatitis B Screening
Undergo 3 HBV screening tests (HbsAg, anti-HBc, and anti-HBs)
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline blood tests, approximately 30 minutes for blood draw

External Links

•   The University of Texas MD Anderson Cancer Center Official Website